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How To Become A Clinical Research Associate - A New Scientist Careers Guide

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What does a clinical research associate do?

Clinical research associates (CRAs) are responsible for running clinical research, which consists of trials designed to test new or current drugs/immunisations and analyse their effectiveness, risks, benefits and safety of use. 

CRAs play an important role in the healthcare industry and public health development by helping to design and test new medications, vaccinations and other therapeutic agents.

CRAs can be involved at any stage of a drug development trial, including planning, coordinating and supervising. It is their responsibility to ensure a drug has been appropriately examined and all its risks have been evaluated before it is released to be used publicly.

CRAs most commonly work for pharmaceutical companies or contract research organisations. They might also have to spend some time working in a hospital setting to collect data about the drugs they are analysing. They might also work for universities or public/global health organisations. 

As a CRA, you may have a range of responsibilities depending on your employer, project and level of experience. Typically, CRAs will need to complete tasks such as:

• Designing and writing trial protocols and standard operating procedures
• Presenting protocols and procedures to steering committees
• Designing data collection forms
• Requesting ethics approvals and working with ethics committees
• Liaising with staff conducting the trials, such as doctors or consultants
• Training local staff based on trial-specific standards
• Monitoring operations during clinical trial data collection
• Collecting completed data collection forms
• Performing data management and analysis, and discussing the results
• Closing trials and finalising reports with the help of a statistician

CRAs will work in a team of other research professionals, including contract organisation or sponsor staff, principal investigators and clinical research coordinators.

How to become a clinical research associate

To become a CRA, you need to obtain a degree in medical sciences, life sciences or nursing. This can be in subjects such as biomedical science , anatomy, physiology, immunology , pharmacology or broader degree subjects like chemistry and biology .

Alternatively, you can access a career as a CRA by acquiring a higher national diploma (HND). This is a qualification equivalent to the second year of a bachelor’s degree. HNDs can be beneficial to those who want to enter more practical fields, clinical research included.

Occasionally, you can enter a CRA role from an administrative background. For instance, if you begin working as a clinical trials administrator/assistant and decide you would prefer the role of a CRA, you can complete additional qualifications to do this. However, this will take some time and can be difficult.

Most employees view undergraduate qualifications as sufficient, but in some cases a postgraduate degree may be beneficial. Master’s degrees and PhDs can gain you an advantage when applying for competitive positions, and help you gain more experience in research .

Work experience is key to securing a clinical research job. You can get this at any point in your training, and some universities may help with this. The types of work experience most useful for a CRA role include:

• Academic research
• Pharmaceutical research (e.g. via a pharmaceutical industry placement during your degree)
• Laboratory work
• Nursing or care work
• Work in a pharmacy or medical sales
• Other, similar activities

How long does it take to become a clinical research associate?

Becoming a CRA will usually take around three to four years, depending on the access pathway you choose.

If you opt to complete an undergraduate degree, this can take three to four years. You can then apply to job positions as a CRA straight away. However, if you don’t have sufficient work experience, you may need to start at a lower-level position such as a more administrative job. From here, you can gain more experience and reapply for a higher-level position.

If you choose to obtain a HND qualification, this will take two years. Provided you have sufficient experience, you can then apply for a graduate post as a CRA, but again you may need to gain some extra experience/qualifications in some cases.

If you opt to do a postgraduate degree first, this may take an additional one to three years depending on whether it is a master’s degree or a PhD. Many CRA job positions also allow for completion of postgraduate qualifications alongside the job.

A day in the life of a clinical research associate

Most CRAs work about 40 hours a week, during weekdays. There may be an out-of-hours commitment, for instance if working in a hospital setting monitoring a new drug, but this is dependent on your employer and role.

CRAs can work on multiple trials at a time, in multiple different sites. This will depend on the complexity of each trial and what stage each of the trials is in. Therefore, the role may entail some travelling at times, while other times most of your work will be concentrated on one site.

As a CRA, you will carry out a wide variety of tasks. Some days may be spent writing reports. On other days, you will work on site with healthcare staff , or you might go into your office and attend meetings.

No matter your experience level or how senior your role is, as a CRA, you will need to work in a team with other research and healthcare professionals. You will be communicating with research nurses, doctors, health consultants, investigators and managerial and administrative staff from the company requesting the trial.

The role requires good communication skills, as well as good time management and organisation skills, because carrying out a few different studies at once may mean some tasks clash with one another and you need to prioritise the most important ones.

Clinical research associate: Career options

As with most clinical roles, CRAs undergo lots of continuing professional development (CPD) within their role. There are many training courses available to CRAs to build on their existing skills and develop new competencies.

Most training courses are organised by external bodies, and many are paid for by the employer. One of the organisations that runs training courses is the Institute of Clinical Research (ICR). It provides training in areas such as effective project management for clinical trials and advanced clinical trial monitoring, among several others.

The ICR also offers certificates and a diploma that you can complete to evidence your skills in clinical research. Becoming an ICR member and obtaining courses and qualifications from it can also be beneficial to career development, as you will meet other prominent professionals in your field through interacting with this organisation.

You can also opt to complete a postgraduate qualification, such as a PhD or master’s degree in several different areas, including clinical research and clinical pharmacology .

As mentioned, you may need to climb up the professional ladder to become a CRA, and many people start off as clinical trial administrators or junior CRAs. Within these roles, you might complete tasks such as handling documentation and correspondence or helping to set up trial sites. 

From here, you can move on to becoming a senior CRA as you gain experience. At this point, you will have more advanced responsibilities, such as project management of whole trials and designing case report forms.

If you develop sufficient experience and gain contacts in the field, there is a possibility of self-employment if you want to become a freelance CRA. 

Salary: How much does a clinical research associate earn in the UK and US?

In the UK, starting salaries for CRAs range between £26,000 and £34,000 per year. As a more senior CRA, you might earn between £35,000 and £50,000, and in the most senior positions involving managerial tasks, you might earn upwards of £55,000.

Salaries will vary between regions and employers, as well as depending on your level of experience and responsibilities. Some companies offer additional benefits.

In the US, the average salary for a CRA is $70,000 per year. The range is between $60,200 and $80,900. This can vary depending on the region you work in, your education and experience levels and any additional qualifications you have.

Salaries will also be different as a freelance CRA, and this will depend on the number of clients you have and any business-related expenses you need to cover.

• Prospects. Clinical research associate. Available from: https://www.prospects.ac.uk/job-profiles/clinical-research-associate (accessed Apr 2024)
• CK Group. Clinical research associate (CRA) job profile. Available from: https://ckgroup.co.uk/candidate/job-profiles/clinical-research-associate-cra-job-profile/ (accessed Apr 2024)
• Nikolova, T. The CRA Wizard. How to become a CRA for dummies in 7 steps (or less). Available from: https://www.thecrawizard.com/how-to-become-a-cra-for-dummies (accessed Apr 2024)
• Glassdoor. Clinical research associate career. Available from: https://www.glassdoor.co.uk/Career/how-to-become-clinical-research-associate_KO14,41.htm (accessed Apr 2024)
• Coursera. How to become a clinical research associate. Published Nov 2023. Available from: https://www.coursera.org/articles/clinical-research-associate
• Walters, L. Pharmiweb.jobs. 8 ways to advance your career as a clinical research associate (CRA). Published Sept 2023. Available from: https://www.pharmiweb.jobs/article/8-ways-to-advance-your-career-as-a-clinical-research-associate-cra- (accessed Apr 2024)
• Salary.com. Clinical research assistant salary in the United States. Available from: https://www.salary.com/research/salary/alternate/clinical-research-assistant-salary (available from Apr 2024)

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Clinical Research Associate

On successful completion of this program, you will be certified and will have acquired knowledge, skills and competencies to start at an entry level role as Clinical Research Associate, In-House Clinical Research Associate or similar.

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Gain a deep understanding of the entire medicines development lifecycle, from research to regulatory submissions.

Learn essential ICH GCP guidelines and navigate regulatory frameworks in the EU and USA, including FDA regulations.

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build a strong foundation in the clinical research field

This first module will help you build a strong foundation in the clinical research field. You’ll explore the key stages of medicines development, from research and discovery to clinical trials and regulatory submissions. Additionally, you’ll master the principles of Good Clinical Practice (GCP) to ensure patient safety and data integrity throughout your research.

Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.

✓ Understand the background of medicines development and its critical processes.

✓ Learn about the research and discovery stages , and how product development progresses.

✓ Explore the phases of clinical development and their significance.

✓ Gain insights into regulatory submission, Health Technology Assessment, and lifecycle management.

✓ Master ICH GCP and other applicable regulations essential for clinical research.

• Lesson 1 - Microcourse: The Medicines Development Process
• Lesson 2 - Microcourse: The Clinical Development Process
• Assignment - Medicines Development and GCP
• Knowledge Check - Medicines Development and GCP

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KHILNA SAMAT

Meet Khilna Samat, a biochemistry major with a passion to connect top talent with opportunities. With experience working at a clinical trials site in the U.S., she has managed phase II-IV clinical trials across multiple therapeutic areas as a skilled Clinical Research Coordinator and played a pivotal role in improving and standardizing the study start-up process at the site as a Study Start-Up Specialist.

MASTER THE REGULATORY LANDSCAPE OF CLINICAL RESEARCH

In this module, you’ll dive into the intricate regulatory environments of the EU and USA. You’ll gain an in-depth understanding of the national and international regulatory requirements, including ICH GCP E6 (R2), and learn the importance of compliance in your professional work. This module will equip you with the necessary skills to handle audits, inspections, and to develop robust quality assurance systems.

✓ Understand the significance of regulatory requirements in clinical research.

✓ Learn about the regulatory systems in the USA and EU.

✓ Master the monitor’s role in audits and inspections.

✓ Recognize and deal with misconduct and suspected fraud.

✓ Develop skills required before, during, and after inspections/audits.

• Lesson 1 - Microcourse: History and Development of Regulatory Requirements in the EU and USA
• Lesson 2 - Microcourse: Regulated Activities in Clinical Research in the EU and USA
• Assignment - Regulatory Environment in the EU and USA
• Knowledge Check - Regulatory Requirements, Compliance and Quality Assurance, Audits and Inspections

GABI DISSELHOFF

Regulatory & Quality expert 38 years in pharmaceutical development

DESIGN YOUR CLINICAL RESEARCH STUDIES WITH PRECISION

This comprehensive module provides an in-depth understanding of clinical trial design and the various roles and responsibilities within clinical research. You’ll delve into the critical components of a study protocol, explore diverse trial design methodologies, and gain insights into the ethical and regulatory frameworks that govern clinical research. Learn from expert Eric Klaver and master the skills necessary to ensure the integrity and success of your clinical trials.

✓ Understand the design features of a clinical trial.

✓ Describe the rationale of complying with any given study protocol to protect patient rights and ensure data integrity.

✓ Learn the roles and responsibilities of each key party in clinical research activities.

• Lesson 1 - Microcourse: The Study Protocol
• Lesson 2 - Microcourse: Clinical Research Roles and Responsibilities
• Assignment - Clinical Trial Design & Clinical Research Roles and Responsibilities
• Knowledge Check - Clinical Trial Design & Clinical Research Roles and Responsibilities

EFFECTIVELY SELECT AND INITIATE CLINICAL TRIAL SITES

This module offers a detailed understanding of how to assess and prepare clinical trial sites. You’ll learn to evaluate investigational sites, implement strategies for site enhancement, and conduct effective site initiation visits. These skills are essential for ensuring successful clinical trials and efficient site management.

✓ Understand the qualities of a good investigator site .

✓ Learn the purpose of an initiation visit.

✓ Plan and organise appropriate training for trial site staff.

✓ Follow up on identified issues and escalate problems as needed.

✓ Encourage investigator sites in patient recruitment using ethical methods.

• Lesson 1 - Microcourse: The Role of a CRA
• Lesson 2 - Microcourse: Site Selection
• Lesson 3 - Microcourse: Site Preparation and Initiation
• Assignment - Selecting and Initiating Clinical Trial Sites
• Knowledge Check - Selecting and Initiating Clinical Trial Sites

ENSURE EFFECTIVE MONITORING AND CLOSURE OF CLINICAL TRIAL SITES

This module provides crucial insights into monitoring and closing clinical trial sites. You’ll learn how to assess site performance, conduct effective monitoring and close-out visits, and develop strategies to address any issues that arise. These skills are essential for maintaining the integrity and efficiency of clinical trials.

✓ Understand the purpose of monitoring .

✓ Prepare and conduct effective monitoring visits .

✓ Assess site performance and develop strategies for improvement where needed.

✓ Prepare and conduct effective close-out visits .

• Lesson 1 - Microcourse: Site Monitoring
• Lesson 2 - Microcourse: Site Closure Visit
• Assignment - Monitoring and Closing Clinical Trial Sites
• Knowledge Check - Monitoring and Closing Clinical Trial Sites

ENSURE PATIENT SAFETY AND MANAGE ADVERSE EVENTS

This module focuses on securing patient safety and handling adverse events in clinical trials. You’ll gain a thorough understanding of the informed consent process, adverse event identification and reporting, and strategies to protect patient confidentiality and data integrity. These skills are essential for maintaining ethical standards and compliance in clinical research.

✓ Know how to encourage investigator sites to conduct patient recruitment ethically.

✓ Verify that the informed consent process has been properly performed and documented.

✓ Understand factors affecting patient safety and data integrity at investigator sites.

✓ Comprehend adverse event reporting requirements .

• Lesson 1 - Microcourse: Patient Protection and the Informed Consent Process
• Lesson 2 - Microcourse: Clinical Monitoring Adverse Events
• Assignment - Patient Protection & Adverse Events
• Knowledge Check - Patient Protection & Adverse Events

MASTER THE MANAGEMENT OF INVESTIGATIONAL MEDICINAL PRODUCTS

This module covers the comprehensive management of investigational medicinal products (IP). You will learn about drug accountability, storage, dispensing, and documentation. The module also addresses randomization and blinding procedures, ensuring compliance with protocols, and FDA inspection findings. These skills are critical for maintaining the integrity and safety of clinical trials.

✓ Understand the key aspects of investigational product management .

✓ Learn the responsibilities of the Sponsor, Monitor, and Investigator.

✓ Conduct IP reconciliation at the end of the trial.

✓ Understand randomization and blinding processes .

✓ Monitor IP-related aspects during visits (drug accountability, storage conditions, etc.).

✓ Familiarize with common findings from FDA inspections .

• Lesson 1 - Microcourse: Investigational Medicinal Product Management
• Assignment - Investigational Medicinal Product Management
• Knowledge Check - Investigational Medicinal Product Management

MASTER DATA MANAGEMENT IN CLINICAL RESEARCH

This module provides essential knowledge on managing clinical trial data effectively. You will learn about the structure and purpose of Case Report Forms (CRFs), accurate data collection, compliance with data validation plans, and the documentation requirements for essential documents. These skills are critical for maintaining data integrity and ensuring regulatory compliance in clinical trials.

✓ Understand the purpose and structure of a Case Report Form (CRF).

✓ Learn the process for accurate data collection.

✓ Ensure that the investigator site is aware of the requirement of archiving essential documents in accordance with applicable guidelines and regulations .

• Lesson 1 - Microcourse: Introduction - Data Management for CRAs
• Lesson 2 - Microcourse: Data Management for CRA Part 1
• Lesson 3 - Microcourse: Data Management for CRA Part 2
• Lesson 4 - Microcourse: Data Management for CRA Part 3
• Assignment - Data Management for Clinical Research Associates
• Knowledge Check - Data Management for Clinical Research Associates

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The typical responsibilities of a CRA can vary depending on the employer, the stage of the clinical trial, and the size of the study team. However, some common responsibilities of a CRA may include:

• Study site management:  CRAs are often responsible for managing the study sites participating in a clinical trial. This may involve conducting site feasibility assessments, training site staff on study protocols and procedures, and monitoring site performance.
• Data collection and review:  CRAs may collect and review study data to ensure that it is accurate and complete. This may involve reviewing medical records, lab reports, and other documentation.
• Adverse event monitoring:  CRAs are responsible for monitoring adverse events reported by study participants and ensuring that they are reported and managed appropriately.
• Regulatory compliance:  CRAs must ensure that the study is conducted in accordance with relevant regulations and guidelines, such as good clinical practice (GCP) and the International Conference on Harmonisation (ICH) guidelines.
• Documentation:  CRAs must maintain accurate and complete study documentation, including case report forms (CRFs), study logs, and other study-related documents.
• Communication:  CRAs must communicate effectively with study team members, site staff, and study participants to ensure that the study is conducted smoothly and that any issues are addressed in a timely manner.
• Subject recruitment:  CRAs may be involved in supporting recruitment of eligible study participants.

Overall, the role of a CRA is multifaceted and requires a high level of attention to detail, organization, and communication skills.

Upon enrollment you will receive your first certification “Confirmation of Enrollment”.  After successful completion of the course and your exam, you get your personal “Course Certificate” including:

• course title
• contact hours
• continuing education units (CEU)
• your overall course score
• date of completion
• personal certificate verification code

We also show you how to best share your certificate on LinkedIn and other social media platforms.

There are several reasons why you might consider getting a CRA certification:

Demonstrated knowledge and commitment:  Obtaining a CRA certification demonstrates to employers and colleagues that you have a strong understanding of clinical research processes, regulations, and best practices. It shows your commitment to your career in clinical research and can set you apart from other candidates when applying for jobs.

Increased job opportunities:  Many employers prefer or require candidates with CRA certifications for their open positions. Having a certification can make you a more competitive candidate and increase your job opportunities.

Career advancement:  A CRA certification can help you advance in your career by opening up opportunities for promotion, leadership roles, and increased pay.

Continuing education:  Many employers require ongoing education and professional development, which can help you stay up-to-date with the latest developments in the field.

Overall, obtaining a CRA certification can help you stand out in a competitive job market, demonstrate your knowledge and commitment to your career, and open up opportunities for career advancement and professional development.

No, you can proceed with the course in your own pace. But please keep in mind, that you might have to purchase a course extension in order to continue learning (check the pricing table above).

To become a CRA, you will  typically need  a bachelor’s degree in a life science or healthcare-related field, such as biology, chemistry, nursing, or pharmacy. However, some employers may accept degrees in other fields if you have relevant work experience.

In addition to a degree, it is  beneficial  to have experience working in the healthcare or research industry. This can include positions such as a research assistant, laboratory technician, or nurse. Other  skills  for a CRA include attention to detail, strong organizational and communication skills, the ability to work independently and as part of a team, and problem-solving abilities. Proficiency in Microsoft Office and other relevant software is also important.

If you are not sure if this is the right training for you,  we are happy to help you make the right decision.  Email us at [email protected] and we will contact you.

What alumni say about this program

I would like to pass it but this days I’m so busy and I don’t have enough time to progress with it

The course is very detailed for its length and gives exactly what one may need to navigate the clinical research landscape and medical science.

VIARES Micro Certificate DATA ANALYSIS

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Clinical Research Associate Academy

VIARES is an amazing learning platform. After completing the Clinical Research Associate program, I feel well equipped to take on the role and responsibilities of a CRA with great confidence. I would definitely recommend it!

VIARES Micro Certificate PHASES OF CLINICAL TRIALS

I have been doing the CRA course for about a month now and so far I am really enjoying it. The lectures are really easy to follow, interesting and informative. I'm looking forward to learning more.

Clinical Trials Assistant Academy

I really enjoyed the course. The content was well condensed to what is really important.

VIARES ACADEMY ALL-In-One

The course is amazing journey into clinical research career attainment with deep insights of course units that are enriching ,from which knowledge and skills are drawn from , the course contents so far are rich and contributive to career progress.

very user friendly and lots of information to gather. Thank you

Clinical Study Coordinator Academy

Very rich course content.

I want to say a big thank you to all VIARES Coordinators, for a well packaged program. It is so easy to understand a well-organized. I have just completed the Clinical Research Associate, it was awesome. I will recommend it to friends.

The CTA was very informative and had a wide topics covered. I am a fresher to the field but now with the knowledge imparted by all the professionals, I feel empowered, Thank you all. Looking forward to complete the other courses in the All in One Academy, Thank you Viares Team

So far my journey here to become a CRA has been so insightful and impactful. I look forward to more exciting topics and lectures as far as the CRA program is concerned.

Very informative yet user friendly

My only critique is with the navigation. When you finish one module it should have an arrow to go to menu of next module The course content is great and informative

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Senior Clinical Research Associate - Oncology experience required

• Location: London
• Categories Clinical Monitoring
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Title: Clinical Research Associate (must have 2 years' experience monitoring Oncology studies within phases 1 and 2 as a minimum) 

Location: United Kingdom, nationwide travel required

Sponsor dedicated 

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

The primary responsibilities of this position include assessing qualifications of potential clinical study sites, implementing clinical studies at participating sites, managing the conduct of clinical studies at sites, ensuring the quality of site performance, and closing clinical studies. This individual will ensure that clinical trials are conducted according to the approved protocol/protocol amendments and complies with Good Clinical Practice (GCP), Company SOPs and all applicable regulatory requirements.

• Responsible for evaluating, initiating, monitoring and closing out clinical study sites.
• Documents all activities in clear, comprehensive and accurate Monitoring Visit Reports, Contact Reports and follow-up letters within required timelines.
• Ensures that the conduct of clinical studies at sites is in accordance with the protocol/protocol amendments, Good Clinical Practice regulations, International Harmonization Guidelines, applicable company Standard Operating Procedures (SOPs), and all applicable regulatory requirements.
• Properly trains/re-trains site personnel on the protocol/protocol amendments, systems utilized in the study, and all operational aspects of the trial.
• Serves as primary contact for site personnel, acting as liaison between site personnel and sponsor study team members.
• Develops patient recruitment strategies in conjunction with the clinical site to meet enrolment timelines.
• Ensures subjects’ rights, safety and well-being are protected.
• Ensures compliance with the procedures to apply in the event of adverse events and serious adverse events.
• Evaluates the quality and integrity of reported data, ensuring that sites enter data into EDC and resolve queries in a timely fashion.
• Assists and supports data validation and data cleaning procedures to ensure timelines are met.
• Identifies, assesses and resolves site performance, quality or compliance problems and develops an appropriate intervention plan for the avoidance of redundant errors and deviations.
• Communicates with Investigators, site staff, Sponsor Study Team Members, and/or QA on issues related to protocol conduct, subject recruitment and retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Maintains audit-ready clinical trial documentation. Collects, reviews, monitors, and files required regulatory documentation during study maintenance and at study closeout. Verifies investigator study records are reconciled with the contents of Sponsor files (Trial Master File).
• Verifies the receipt, handling, accounting, storage conditions and availability of study medications under investigation.
• Ensures availability of non-clinical materials for sites.
• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Gains an in-depth understanding of study protocols and related procedures.

You must have the following to be successful in this role:

• Position requires BA/BS , preferably in the Life Sciences, or RN.
• Minimum of 2+ years of experience in the pharmaceutical / biotechnology industry monitoring as a Clinical Research Associate from study start-up to database lock.
• Strong Oncology monitoring experience in phase 1-3 pharmaceutical/ biotechnology clinical trials.
• Possess good understanding and working knowledge of ICH guidelines, Good Clinical Practices (GCP), PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, and other relevant, local regulatory requirements.
• Good knowledge of concepts of clinical research and drug development.
• Strong working knowledge of EDC, IVRS and CTMS systems.
• Proficiency in the use of the Microsoft Office.
• Ability to handle and prioritize multiple studies and projects.
• Ability to work effectively in a team/matrix environment.
• Ability to understand technical, scientific and medical information.
• Demonstrated strengths in planning, organizational, project management, analytical, oral/written communication, effective time management, conflict management, problem solving, attention to detail, and interpersonal skills.
• Works with high quality and compliance mindset.
• Possess a valid UK driver’s license.
• Must be willing to travel and spend 6-8 days /month on site.
• Ex-US: Proficient in speaking and writing English and the country language when applicable.

What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. https://careers.iconplc.com/reasonable-accommodations Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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To excel as a Clinical Research Associate (CRA) in a Clinical Research Organization (CRO), you need a combination of education, skills, and the right mindset. Brazil-based CRA II Debora shares her

Brazil-based CRA II Debora Oh shares her tips on how to become a great CRA and provides insight into life at ICON.

How to progress as a Clinical Research AssociateTo thrive as a Clinical Research Associate (CRA), it is imperative to cultivate a multifaceted skill set and demonstrate unwavering commitment to exce

 Senior CRA Yemi Moses recounts her development and shares her career ambitions with ICON plc.

Senior Clinical Research Associate Suzaita Hipolito talks about the satisfaction gained from working in Clinical Research. “What would it look like to wake up every day feeling happy and fulfilled?

Senior Clinical Research Associate, Suzaita Hipolito, talks about how working in Clinical Research gives her happiness and fulfilment.

Suzaita Hipolito

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ACRP Certification

With a 30-year legacy, acrp certification is the most reputable credentialing program in clinical research. since 1992, more than 40,000 professionals and their employers have come to trust acrp certification as the mark of excellence in clinical research., “joining acrp and becoming certified was the best thing i ever did to jumpstart my career in research and has opened many doors for me.”, jeri burr, ms, rn, ped-bc, ccra, facrp acrp certified since 1999, benefits of certification >, start your next career journey by exploring acrp’s flagship certification and subspecialty credential programs below. each program provides specific information and resources on exam eligibility, exam content, how to apply, scheduling & testing, how to prepare, and after your test. if you have questions, explore the faq page or the acrp certification handbook ., acrp certified professional, acrp-cp ® is a credential formally recognizing clinical research professionals of all types, regardless of their roles or functional activities on the clinical study team., learn more >, certified clinical research associate, ccra ® is a credential formally recognizing clinical research professionals with experience monitoring and supervising the conduct and progress of clinical trials on behalf of a sponsor., certified clinical research coordinator, ccrc ® is a credential formally recognizing clinical research professionals with experience coordinating and facilitating clinical trial activities in adherence to gcp, under the direction of a principal investigator., certified principal investigator, cpi ® is a credential formally recognizing clinical research professionals with experience as a principal investigator or sub investigator on multiple studies., acrp medical device professional, acrp-mdp ® is a credential formally recognizing clinical research professionals with specialized knowledge in medical device clinical trials. candidates must be acrp certified to sit for this exam., acrp project manager, acrp-pm ® is a credential formally recognizing clinical research professionals with specialized knowledge in project management. candidates must be acrp certified to sit for this exam., the academy’s acrp-cp, ccrc, ccra, and cpi programs are accredited by the  national commission for certifying agencies (ncca),  which sets internationally recognized standards for the development and operation of certification programs. the standards assure that a program is valid, reflects current practice, and treats candidates fairly and are based on the established processes for developing certification exams., the most respected certification thought leaders in the country agree that ncca accreditation is the gold standard when it comes to accreditation of programs that certify professionals working in healthcare—including the clinical research industry. when you’re searching for certification programs, make sure you always look for the ncca-accredited program seal., bring certification to your team —acrp certification is an ideal solution for managers looking to enhance team knowledge, grow leaders, and signify to others that their study teams are among the best of the best. learn more >.

What Is a Research Associate?

In today’s rapidly evolving world, research plays a crucial role in driving innovation, shaping policies, and advancing knowledge across various industries. At the heart of this progress lies the position of a Research Ass ociate —an essential contributor to the success of research projects in academia, corporate settings, and other research-driven sectors. But what exactly is a Research Associate, and why is this role so critical? In this blog, we will explore the responsibilities, required skills, qualifications, and potential career paths for Research Associates, highlighting their significance in the broader context of research and development.

What Does a Research Associate Do?

A Research Associate works as part of a research team, conducting experiments, analyzing data, and contributing to publications or reports that present the findings. The specific tasks of a Research Associate can vary widely depending on the industry and the focus of the research, but generally, their duties involve:

Data collection and analysis : Research Associates gather and analyze data from experiments, surveys, or existing databases. They ensure the accuracy of this data, which forms the foundation of research findings.

Conducting experiments or fieldwork : Whether in a laboratory, a clinical setting, or out in the field, Research Associates are often involved in conducting experiments, managing laboratory equipment, and ensuring that experimental procedures follow protocols.

Literature review : To stay informed and relevant, Research Associates review existing studies and publications on their research topic to identify gaps or build on existing knowledge.

Reporting and publication : Writing up the findings is a critical task. Research Associates help prepare reports, papers, or presentations that summarize the research outcomes. They may also contribute to academic publications or corporate reports.

Collaboration with team members : Research Associates work closely with principal investigators, senior researchers, or project leads. They collaborate with team members to refine research methodologies and contribute their expertise to achieve project goals.

The role of a Research Associate is vital in ensuring that research projects are completed on time and with high-quality, accurate results. Whether in academia, healthcare, pharmaceuticals, finance, or technology, Research Associates contribute significantly to the advancement of their field.

Skills and Competencies Required for a Research Associate

To excel as a Research Associate, an individual must possess a combination of hard and soft skills, including technical expertise, critical thinking, and teamwork. The specific skill set varies based on the field of research, but common competencies include:

1. Analytical Skills

Research Associates must be proficient in collecting and analyzing large datasets. Whether using statistical software, conducting qualitative analysis, or drawing conclusions from scientific experiments, having strong analytical abilities is critical to generating meaningful insights from data.

2. Technical Proficiency

Many Research Associates work with specialized software or equipment. For example, in the field of biology, Research Associates may work with lab instruments, while in social sciences, they may need to master statistical software like SPSS or R. Therefore, understanding the technical aspects of data analysis, laboratory procedures, or industry-specific research tools is key.

3. Attention to Detail

The integrity of research data depends on meticulous attention to detail. Research Associates must ensure that they follow protocols precisely, maintain clean data sets, and identify any anomalies in their findings. Missing or incorrect data can lead to skewed results, making this skill indispensable.

4. Communication Skills

Research Associates must communicate their findings clearly and concisely. Whether through written reports, presentations, or collaborative discussions with senior researchers, conveying complex information in an understandable format is an important part of the job.

5. Teamwork and Collaboration

Most research projects involve collaboration between multiple stakeholders, such as senior researchers, faculty members, or corporate project managers. Research Associates need to be comfortable working in a team environment and contributing to joint decision-making processes.

6. Problem-Solving Abilities

Research rarely follows a predictable path. Experiments can fail, data can be incomplete, or new questions may arise during the study. Research Associates must be adaptable and able to think critically to troubleshoot issues as they arise.

7. Time Management

Many research projects have strict deadlines, often imposed by funding bodies or corporate clients. Research Associates must be able to prioritize their tasks, manage multiple responsibilities simultaneously, and ensure that they meet project timelines.

Qualifications and Educational Background for Research Associates

Becoming a Research Associate typically requires a strong educational background, often at least a bachelor’s degree in a relevant field. In many industries, employers may prefer candidates with a master’s degree or higher, particularly for more complex research roles. Below are some typical qualifications and academic pathways for a Research Associate:

Bachelor’s Degree : In most cases, a bachelor’s degree in the field relevant to the research is the minimum requirement. Common disciplines include biology, chemistry, social sciences, economics, engineering, or psychology. Coursework in research methodology, statistics, and data analysis is often highly valued.

Master’s Degree : Many Research Associates hold a master’s degree, which provides advanced training in research techniques and often includes a significant component of independent research. This qualification is particularly important in competitive fields like healthcare, pharmaceuticals, or biotechnology.

Doctoral Degree (Optional) : While not a strict requirement for Research Associates, holding a Ph.D. can offer opportunities for more senior roles or lead to career advancement into positions such as Research Scientist or Principal Investigator.

Certifications and Additional Training : In some industries, specialized certifications or training may be required to use specific equipment or conduct certain types of research. For instance, certification in clinical trials or laboratory techniques can enhance employability in healthcare and pharmaceuticals.

Career Path and Opportunities for Advancement

The role of a Research Associate offers a broad range of career opportunities. Many professionals begin their careers as Research Assistants, gaining initial experience in data collection and basic research techniques, before advancing to the role of Research Associate. From there, further career progression is possible based on experience, education, and the nature of the research.

1. Senior Research Associate

With sufficient experience, Research Associates may progress to Senior Research Associate positions, taking on more responsibility in research design, data interpretation, and project management. This role often involves mentoring junior staff or research assistants.

2. Research Scientist

In many fields, Research Associates can transition into Research Scientist roles. These positions allow for greater independence in conducting research and are often the first step towards becoming a Principal Investigator or leading research teams.

3. Principal Investigator or Research Manager

After gaining significant experience, Research Associates can move into Principal Investigator roles. Here, they design and lead research projects, secure funding, and oversee the work of other researchers. Research Managers may focus on administrative tasks, managing research budgets, timelines, and teams across multiple projects.

4. Academia and Teaching

Some Research Associates move into academia, using their experience to teach at the college or university level. Teaching allows professionals to mentor the next generation of researchers while continuing to contribute to academic research.

5. Industry-Specific Roles

Many industries, such as pharmaceuticals, healthcare, and technology, offer specialized roles for Research Associates. For example, in the biotech field, Research Associates might work on drug discovery or clinical trials, while in finance, they might focus on market research or investment analysis.

The Impact of Research Associates

Research Associates are the unsung heroes behind many of the scientific, social, and technological advances we benefit from today. They work diligently to gather data, analyze results, and contribute to the production of new knowledge. Whether in academia, healthcare, finance, or any other industry, their work drives innovation and improves our understanding of the world.

As we continue to rely on research to solve global challenges—from healthcare crises to climate change—the role of the Research Associate will remain essential. For individuals considering a career in this field, it offers a diverse and rewarding career path with opportunities for growth, innovation, and contribution to meaningful work.

In summary, a Research Associate’s contributions are invaluable to the success of research initiatives, making it a fulfilling career choice for anyone with a passion for data, critical thinking, and a curiosity about the world.

National Institutes of Health (NIH) - Research Associate Role and Responsibilities https://www.nih.gov

American Psychological Association (APA) - Careers in Research https://www.apa.org/careers/resources/research/

The Chronicle of Higher Education - Research Associate Job Outlook https://www.chronicle.com/

University of Cambridge - Research Associate Job Description https://www.jobs.cam.ac.uk/job/

National Science Foundation (NSF) - Research Career Pathways https://www.nsf.gov/

What Are the Therapeutic Areas of Clinical Research?

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Clinical research roles: how to become a clinical research associate, clinical research associate job description.

Clinical research associates (CRAs) are key actors in facilitating and ensuring successful clinical trial operations. A CRA in clinical research plays an essential role in the trial’s logistics, acting as a liaison between trial sites and the sponsor, and interacting with patients.

What is a clinical research associate?

A clinical research associate (CRA) is responsible for ensuring that clinical trials follow regulations, protocols, and Good Clinical Practice (GCP) guidelines.[ 1 ] The job description of a clinical research associate is centered on monitoring clinical trials to ensure they are conducted safely and effectively, and facilitating communication and coherence between sites and the sponsor. Their duties could include:

• Site selection: CRAs may be involved to varying degrees in selecting appropriate clinical trial sites as well as performing pre-trial site screening visits to verify their capacity to conduct the trial
• Protocol development: CRAs may help the sponsor/investigators develop the clinical trial protocol
• Study start up: CRAs assist with study start up activities, including obtaining regulatory approvals, collecting documentation, training site staff, and conducting site initiation visits
• Site visits: A core responsibility of the CRA is to visit the trial sites, both during the trial (to ensure protocol and regulatory compliance), and after the trial (to perform site close-out)
• Site monitoring: CRAs verify that sites are following the data management plan and protocols to help ensure data is accurate and complete
• Safety monitoring: CRAs may monitor patient safety throughout the trial, including adverse event reporting and serious adverse event management
• Regulatory compliance: CRAs ensure that clinical trials are conducted according to legal and ethical regulations and GCP guidelines

Other potential names for this position include clinical research monitor, clinical trials coordinator, clinical research scientist, or clinical research manager.

Qualifications: How to become a clinical research associate

To become a clinical research associate, you typically need a bachelor's degree in a relevant field such as biology, life sciences, or nursing. A degree in a field that is related to clinical research is generally preferred but is not required for all positions. Some employers may require additional qualifications, such as a master's degree or specialized certification.

In addition to formal education, experience working in the medical research industry is highly desirable. Many CRAs start their career in clinical research working under the supervision of experienced clinical research professionals.

Some of the skills needed to perform the job functions of a CRA include:

• Strong attention to detail and organizational skills
• Excellent communication and interpersonal skills
• Ability to work both independently and as part of teams
• Knowledge of the pharmaceutical and healthcare industries, health and life sciences, and clinical trial processes, regulations, and guidelines
• Analytical and problem-solving skills
• Proficiency in data management and analysis software

If you do not have a relevant degree or prior experience, there are still ways to break into the field of clinical research as a CRA. Here are a few tips:

• Look for entry-level clinical research jobs: Many companies offer entry-level clinical research associate jobs for individuals who do not have prior experience in clinical research. These positions may involve assisting CRAs with managing study activities or administrative tasks.
• Volunteer: Volunteering for clinical research organizations (CROs), research hospitals conducting trials, or other clinical research companies can provide valuable experience and demonstrate your interest in the field. Further, this experience may count as relevant work experience and could qualify you to take the ACRP CRA certification exam (see next section)

Clinical research associate certification

Several courses and clinical research certifications can help you land a CRA job. Two of the most in-demand clinical research associate certifications include SOCRA’s Certified Clinical Research Professional (CCRP) certification and the Association of Clinical Research Professionals (ACRP)’s Certified Clinical Research Associate (CCRA) certification.[ 2 ],[ 3 ] A CRA certification can help demonstrate your knowledge and skills to potential employers.

Similarly, the Certified Clinical Research Professionals Society (CCRPS) offers an Advanced Clinical Research Associate Certification (ACRAC) and course which covers clinical research protocols, clinical trials regulations set by the FDA, Good Clinical Practice (GCP), ICH guidelines, and more.[ 4 ] On a more general level, Coursera offers a specialized certification in Medical Terminology led by Rice University to help you get started on various career paths in the medical field.[ 5 ]

Where to look for clinical research associate jobs

Clinical research associates typically work for pharmaceutical companies, contract research organizations (CROs), academic institutions, or government agencies involved in conducting clinical research. They work closely with a team of clinical research professionals, including principal investigators (PIs), clinical research coordinators (CRC), data managers, and sponsors.

You may be able to find job openings directly with such companies by surveying their websites for open positions. However, you can also look for CRA jobs on job boards such as Indeed[ 6 ] or LinkedIn[ 7 ].

What is the average clinical research associate salary?

The average clinical research associate salary in the United States is around $81,826 (as of when this article was written), with a lower range of $49,052 and a higher range (senior clinical research associate salary) of around $136,499.[8] Salary will depend on multiple factors: level of experience, education, other certifications/qualifications, skillset, and the specific employer.

Clinical Research Associate job outlook

The job outlook for clinical research associates is quite positive, with the high demand for professionals in this field expected to continue. According to the Bureau of Labor Statistics, the employment of medical and health services managers, which includes clinical research associates, is projected to grow 28% between 2021 and 2031.[ 9 ]

In addition, the pharmaceutical and biotech industries are constantly developing new drugs and therapies, which must go through clinical trials before they can be approved. In the USA alone, there are currently over 400,000 active clinical trials.[ 10 ] Thus, there is high demand for professionals with the skills and knowledge to oversee these trials, ensure they are conducted safely and ethically, and optimize their success, particularly in the context of recent advances in technological adoption and new trial models. Moreover, CRA salaries have increased by an average of 15% over the past five years.[ 11 ]

Becoming a clinical research associate is a challenging yet rewarding career path requiring unique skills and qualifications. If you are passionate about medical research and want to make a difference in patients' lives, and you like working with diverse teams on large projects, this may be a promising career path for you. With the proper education, a CRA training program, and some relevant experience, you can become a vital part of the clinical research industry and contribute to the development of new treatments and therapies.

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Popular guides.

• Program Overview

The SOCRA Certified Clinical Research Professional (CCRP) program is your gateway to excellence in clinical research. Elevate your career with our internationally recognized certification, tailored for professionals dedicated to upholding the highest standards in the field. Join a community committed to ethical practices, continuous learning, and advancing global health. 

The Society of Clinical Research Associates (SOCRA) established the Certification Program for Clinical Research Professionals in order to create an internationally accepted standard of knowledge, education, and experience by which clinical research professionals will be recognized by the clinical research community. Those individuals so recognized may use the "Certified Clinical Research Professional" or "CCRP ®  " designation.

Path to Certification

CCRP certification is awarded upon meeting two criteria: a successful written application and a passing CCRP examination score. The benefits of obtaining certification are numerous. It not only validates knowledge, skills, and abilities but also enhances credibility and peer recognition. Career advancement and increased earning potential become tangible outcomes, reflecting a commitment to standards, compliance, and integrity.

Scope and Standards of Practice 

The standards upon which this certification program is based have been set forth by SOCRA to promote recognition and continuing excellence in the ethical conduct of clinical trials.  It is the goal of SOCRA to encourage members, and assure the competency of certified members, in their knowledge, understanding, and application of the conduct of clinical investigations involving humans in accordance with the ICH Guidelines, the U.S. Code of Federal Regulations, and the ethical principles that guide clinical research. Members are expected to adhere to national, state, local and provincial regulations and to international guidelines published by the International Conference for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and all applicable federal, state and local laws and policies.  

Standards of Practice include an understanding of and application of basic concepts of Good Clinical (Research) Practice, including:

• The Nuremberg Code
• The Belmont Report
• The Declaration of Helsinki
• 21 U.S. Code of Federal Regulations – Parts 11, 50, 56, 312, 812
• 45 U.S. Code of Federal Regulations - Part 46
• ICH Harmonised Guideline for Good Clinical Practice E6(R2), and
• ICH Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A)
• 42 CFR Part 11 (ClinicalTrials.gov) 

Certification Exam

The SOCRA Certification Examination is offered in two formats: paper and pencil (at SOCRA sponsored sites), and computer based (at Prometric testing centers or through Home Proctoring).

SOCRA Sponsored Sites: Paper and Pencil

• Hosted exams offered in various location throughout the US and Canada.
• Visit the paper and pencil exam schedule for dates and locations.
• A complete application must be received by the deadline date as stated on the examination schedule.
• Score reports mailed to you in 4-6 weeks after exam.

Computer Based Testing: Testing Centers and Remote Proctoring 

• Offered at Prometric testing centers throughout the world or through Home Proctoring 
• Click here  for a list of test centers.
• Allow 2-4 weeks for application processing. 
• Once application is approved, schedule exam at a testing center.  Exam sessions are available at least 6 weeks in advance.  
• Score reports received immediately upon completion of exam. 

Candidate Handbook

For more information, please view the  Candidate Handbook.

Certification

• CCRP Certification Quick Facts
• Definition of a Clinical Research Professional
• Certification Program Policies
• Removal of CCRP® Credential
• Verify Certification
• Exam Overview
• Candidate Eligibility
• Application and Fee
• Computer Based Testing Exams
• Paper and Pencil Exams
• Refunds, Rescheduling and Retesting
• SOCRA Sponsored Exam Schedule
• Preparing for the Exam
• Preparation Resources
• Examination Results
• Host an Exam at Your Site
• Apply Online
• Exam Schedule SOCRA Sponsored Sites
• Requirements for Maintaining Certification
• Continuing Education Requirements
• Descriptions of Acceptable CE
• CE Recordkeeping Requirements
• Request for SOCRA CE for Courses / Workshops
• Installment Plan Payment
• Renewal of Certification
• Recertification Audit
• Recertification Learning Module
• Accreditation

Summary of Certification Activities

11,145 CCRPs (as of 12/31/2022)

• 1,391 candidates took CCRP exam
• 73% passed CCRP exam
• 2,649 CCRPs recertified
• 946 candidates took CCRP exam
• 65% passed CCRP exam
• 2,783 CCRPs recertified
• 2,060 candidates took CCRP exam
• 70% passed CCRP exam
• 3,801 CCRPs recertified
• 1,980 candidates took CCRP exam
• 71% passed CCRP exam
• 3,188 CCRPs recertified
• 104 exam sites hosted
• 2,175 candidates took CCRP exam
• 2,491 CCRPs recertified
• 91 exam sites hosted
• 2,141 candidates took CCRP exam
• 2,421CCRPs recertified

• Study Team Research Trainings
• Education & Training

Links to various research trainings are below. 

The Johns Hopkins School of Nursing offers a 3 day course which is available 3-4 times a year. Tuition Remission is accepted.  http://learn.nursing.jhu.edu/face-to-face/courses/research-coordinator/index.html

The Johns Hopkins training portal offers the following online training modules (note, some are required courses for IRB Study Teams (noted with *) My Learning can be accessed through  https://my.jh.edu/portal/web/jhupub/

Recommended Modules:

• Basic Human Subjects research CITI*
• Conflict of Interest: COI*
• Clinical Research Management System: CRMS*
• Research Billing*
• HIPAA for Research*
• Pregnancy Testing
• Electronic Patient Record: EPR
• Bloodborne Pathogens
• DOT/IATA Shipping
• Good Clinical Practice CITI

Other research related courses are often offered and may be found by browsing the offerings on the portal.

https://ictr.johnshopkins.edu/education-training/staff/research-coordinator-skills/

https://www.hhs.gov/ohrp/education-and-outreach/human-research-protection-training/participant-centered-informed-consent-training/index.html

JHMIRB offers training for the electronic IRB system. Online training and tutorials can be found here:  http://www.hopkinsmedicine.org/institutional_review_board/training_requirements/eirb_training.html

JHSPH offers a graduate level course entitled “Science of Clinical Investigation” information about the SOCI Course can be found here:

http://www.jhsph.edu/academics/graduate-training-programs-in-clinical-investigation/advanced-training/

ACRP offers education and certification for research professionals

Main Website:  http://www.acrpnet.org/MainMenuCategory/Certification.aspx

ACRP offer several certifications for different professions:

• One for Clinical Research Coordinators  ( http://www.acrpnet.org/MainMenuCategory/Certification/CRCCertification.aspx )
• One for Clinical Research Associates ( http://www.acrpnet.org/MainMenuCategory/Certification/CRACertification.aspx )
• One for Principal Investigators  ( http://www.acrpnet.org/MainMenuCategory/Certification/PICertification.aspx )

SoCRA offers education and certification for research professionals

Main Website:  http://www.socra.org/

SoCRA offer one certification exam that covers all research professional.  http://www.socra.org/certification/certification-program-overview/introduction/

MAGI offers training and certification for research contract professionals

Main Website:  https://magiworld.org/

MAGI offers a certification for Clinical Research Contract Professionals.  https://magiworld.org/certification.php

Coursera is a free online education website that offers college and graduate level classes on a variety of topics – include clinical research.

Website:  https://www.coursera.org/

Information and forms regarding Tuition Remission can be found on the benefits website at:  http://benefits.jhu.edu/tuition/remission.cfm

• Johns Hopkins Institute for Clinical & Translational Research 750 E. Pratt Street, 16th Floor Baltimore, MD 21202
• 410.361.7880
• [email protected]

Funded by the National Center for Advancing Translational Sciences through the Clinical & Translational Science Awards Program, grant number 1UM1TR004926-01.

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Job Description

Westat is an employee-owned corporation providing research services to agencies of the U.S. Government, as well as businesses, foundations, and state and local governments. Westat's research, technical, and administrative staff of more than 2,000 is located at our headquarters in Rockville, Maryland, near Washington, DC.

Westat is committed to building a diverse workforce and a culture of inclusivity, belonging and equity for all. We believe that our greatest strength draws on the different backgrounds, cultures, perspectives and experiences of our employees. Westat’s Health Sector is seeking a highly motivated and experienced Associate Vice President (AVP) with strong business development, client management, project leadership, and clinical research experience to join our leadership team in the Clinical Research Practice. You will have a proven track record in spearheading business development in clinical research, with significant experience managing large-scale projects and securing contracts with federal agencies. The AVP will be responsible for helping to grow our Department of Health and Human Services (HHS) portfolio by leading various capture activities and directing existing or new projects of varying sizes. This is a remote eligible role. Job Responsibilities: •Serve on the Clinical Research Practice’s leadership team to foster growth and develop/implement initiatives ensuring an overall culture of quality and excellence. • Develop and implement strategic plans to expand the company’s clinical research services within HHS agencies. • Lead business development and capture for opportunities within the National Institutes of Health (NIH) and other federal agencies. • Build and maintain strong relationships with federal clients to secure new business opportunities. • Direct and manage large clinical trials support services contracts or a series of smaller projects including leading design, data collection, analysis, and publication. • Lead and mentor a team of clinical research professionals, fostering an environment of continuous improvement and innovation while ensuring billability. • Collaborate on cross-practice initiatives and serve as a thought leader both internally and externally. • Represent Westat at industry conferences, workshops, and networking events to promote our services and expertise. Basic Qualifications: • Master’s degree in biological sciences, clinical research, public health, or related field; PhD and/or PMP preferred. • 10+ years of progressive project and team leadership experience in clinical research. • Successful track record of business development in government contracting, specifically with NIH and/or FDA. • Demonstrated understanding of U.S. government regulatory compliance including but not limited to Human Subjects Protections and Good Clinical Practice. • Experience mentoring research staff at all levels. This Associate Vice President role is viewed as a thought leader within Clinical Research. Strong communication skills and interpersonal skills are essential. The successful candidate must be highly organized, detail oriented, able to take initiative, as well as direction from leadership. Must be capable of managing multiple tracks of complex business activities simultaneously. Must be effective working both independently and in teams with a commitment to fostering a collaborative, inclusive, and innovative work environment.

Clinical Research Associate (CRA) Professional Certification Program

Additional Information:

Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment for each course within a 12-month period. Certificate of completion is accessible in PDF format immediately after satisfying the requirements.

Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score.

Once all training requirements have been satisfied a professional certification has been achieved and can be verified immediately from our website using a unique ID code located on the certificate. The professional certificate of completion is also instantaneously launched and made available to the student in a PDF format. Certificates are issued in an encrypted PDF format, and include a watermark, unique validation code, and QR verification barcode. Furthermore, a digital badge is also issued. The digital badge documents all the courses taken and completed within the program, to further validate the student's achievement. Digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Badgr, and others, to display accomplishments.

Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity or recertification period for employee compliance training would be determined by those responsible for managing quality within the company.

Benefits of Being Certified from Biopharma Institute: Throughout our training students will be engaging in active learning using interactive eLearning modules validated by 3rd party organizations for relevancy, compliance, and regulatory content. Courses are developed by subject matter experts (SMEs) and instructional design professionals with the goal to promote the students' retaining of key knowledge. The programs further offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 300 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity. We supply our training to clinical research, pharmaceutical, and medical device industries.

Employee / Corporate Training: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training; Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We catering to both small-scale and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.

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• GMP: Good Manufacturing Practice
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• FDA 21 CFR Part 11: Electronic Records
• FDA 21 CFR Part 117: GMP Food Mfg.
• FDA 21 CFR Part 111: GMP Dietary
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• Clinical Research Training Programs
• CRA: Clinical Research Associate
• CRC: Clinical Research Coordinator
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• CSV: Computer System Validation
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Copyright 2024 - Biopharma Institute. All Rights Reserved.

Working together, we can reimagine medicine to improve and extend people’s lives.

Senior Clinical Research Associate - Poland (home-office)

About the role.

Major accountabilities:

• Frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliverables with true ownership mindset
• Manages assigned study sites, conducting phase I-IV protocols according to the Monitoring Plan and Novartis procedures
• Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects. Performs continuous training for amendments and new site personnel as required. Re-trains site personnel as appropriate
• Conducts continuous site monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol, ICH/GCP, global and local regulation including Health Authorities, IRB/EC, data privacy requirements, global and local processes as applicable. Documentation according to GDP and Novartis standards.
• Identifies deficiencies in site processes and monitor site processes performed outside the site, works in close collaboration with site on risks mitigation and process improvements
• Promotes a compliance culture advocating adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times
• Establish a strong partnership and true collaboration with the site, to increase patient density and decrease issues at site.
• Early engagement with site on patient inventory and patient flow in advance of SIV in close collaboration with global and local study team
• Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements
• Attends onboarding-, disease indication and project specific training and general CRA training as required
• Proactively collaborates with the SSO Clinical Project Manager (CPM) and CRA Manager as well as MSL, CRMA and medical advisor to ensure optimal recruitment, site development and data quality
• Ensures that relevant site insights are shared with internal stakeholders such as site partnership manager, medical advisor, MSL and CRMA etc. to improve one Novartis approach to sites
• Participates in audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines
• Collaborates with internal stakeholders and site personnel to manage data query resolution process and to ensure timely and accurate data entry
• Ensures the site Investigator Folder is up to date. Responsible for collecting essential documents from site and accountable to keep sTMF(s) up to date

Minimum Requirements:

• Degree in scientific or healthcare discipline
• Fluent in both written and spoken English and Polish
• Minimum 3 years pharmaceutical industry experience or other relevant experience
• 1+ years field monitoring experience is must
• Risk-based monitoring experience is desirable
• Excellent time management and organization capabilities, including ability to prioritize and multi-task
• Risk based mindset
• Good knowledge of drug development process specifically clinical trial/research
• Clinical and therapeutic knowledge
• Knowledge of international standards (GCP/ICH, FDA,EMA)
• Fast change adaptability to best partner & influencing with sites on fast changing landscape
• A minimum of 50% overnight travel may be required
• Good communication skills, ability to influence others &Relationship management
• Excellent communicator and presenter (oral andwritten)
• Ability to manage sites independently; Proven ability to work independently with minimal supervision
• Good analytical thinking
• Digital & tech capabilities

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:

https://www.novartis.com/about/people-and-culture

Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Join our Novartis Network :

If this role is not suitable to your experience or career goals but you wish tostay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:

https://talentnetwork.novartis.com/networkhttps://talentnetwork.novartis.com/network

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

• Steps To Enroll

Certificate Program for Clinical Research Associate (CRA)

Become A Certified Clinical Trial Monitor with this online and self-paced training program. This online CRA Certification course will train you to efficiently monitor & coordinate the day-to-day trial activities of a Clinical Trial Monitor in compliance with the applicable regulatory guidelines.

Learning Objectives

Testimonials, about this course.

A Clinical Research Associate (CRA) or a Clinical Trial Monitor is primarily responsible to monitor, administrate, and supervise the overall progress of a trial. Effective clinical trial monitoring is essential to ensure smooth conduct and progress of clinical trial activities. This ultimately helps to generate quality research data for analysis and trial results.

If you are looking to start or advance your career as a CRA or you are already a Clinical Research Associate without any formal training, the course Certification for Clinical Research Associate” will certify and develop the skills to become a successful CRA.

CPCRA is an online & self-paced certificate program that will provide you comprehensive training on scientific, financial, practical, ethical, and technical concepts of clinical trial monitoring. This 10 weeks training course covers in-depth training for the role of clinical research associate (CRA) in 15 modules covering 150+ topics. Each module is well explained in detail with the help of illustrations, mock training, templates, examples, and flowcharts.

Who Should Enroll?

The course can be attended by:

Clinical Research Coordinators, Research Assistants, and Nurses looking to advance their career as Clinical Trial Monitor.

Newly appointed Clinical Research Associate (CRA)

Experienced CRAs interested in certification

Any researcher and healthcare professional who is looking to take the training & start their career as a Clinical Research Associate (CRA)

$256 $320   20% Off

Course Highlights

20% Fee Discount until September 30

Last Date: September 30, 2024

Online and Self-paced Learning

Single Online Exam

Approx. 40 Hours of Effort

Global Acceptance

Course Curriculum

Module1: introduction to clinical research, module 2: evolution of ethics, regulations & guidelines, module 3: essential clinical trial documents, module 4: investigator site selection & assessment, module 5: development of monitoring plan, module 6: site initiation, documents review & delegation of duties at sites, module 7: clinical trial monitoring, module 8: inventory planning & tracking, module 9: source document verification (sdv), module 10: crf review, collection & coordination of data management, module 11: sae review & regulatory compliance, module 12: ip accountability & management, module 13: escalation, prevention & management of violation/ deviations, module 14: tracking of enrolments, payments & ongoing correspondence, module 15: site closure, assessment through mock hands-on training online exam, how does this work.

You will get the course access details within 48 hours of enrollment.

After that, you can log in to take the course modules at your pace and timings from any device.

After finishing all the course modules, you have to attempt and submit an online exam. The exam is also self-paced. 

After reviewing your exam, the certificate of completion will be issued to all the successful participants of the batch.

This course will help you to:

Develop required skills-set to effectively monitor and administer clinical trial sites.

Identify and define all the procedures to successfully plan, execute, monitor and control the activities of a trial.

Independently plan and execute global monitoring visits.

Learn the process of safety reporting requirements.

Identify, manage and report the trial deviations.

Effectively manage pre, during and after trial job functions in a time-bound manner.

Learners From Top Schools and Companies

To date, learners from 40+ countries and 105+ prestigious global schools and organizations are enrolled in this course.

Average Rating

I loved the mock hands-on training part of the clinical trial monitoring course. It was the first of its kind experience.

Study Coordinator

Covers enough content for beginners and the exam structure was very good.

Research Assistant

I am new to research. CRC & CRA training has helped me to update my knowledge of clinical research.

Clinical Trial Monitor

The course modules were very easy to understand and the information is very well presented.

Research Coordinator

Great and very informative for all the researchers looking to advance their careers in clinical research.

Trial Investigator

I learned a lot from this course. It covers most of the aspects of clinical trial monitoring.

Medical Assistant

Is this the entire course fee?

Yes, the fee mentioned above is the entire course fee and there is no additional fee attached to this course. The fee covers the cost of course modules, online exams and certification of completion.

Do I have to take the course at specific timings?

There is no need to take the course module at particular timings. The course is self-paced and you can take the modules anytime.

Can I complete the course early also?

Yes, you can. To do so, you have to attempt and submit the online exam for evaluation.

I am busy with my professional work/ studies. What if I don’t complete the course on time?

In this case, you can extend the timelines to complete the course. You can do so by dropping a request email in advance with your registered email id at info@physisglobalacademy.com

What if I don’t clear the exam?

Though the course modules are self-explanatory and you can comfortably clear the exam if you go through all the course modules. But in case you are unable to clear it in your first attempt then you will get a second (final chance) to attempt the exam.

How can I pay the fee?

To pay the course fee, follow the link STEPS TO ENROLL or you transfer the applicable course fee directly through your PayPal account to our PayPal account at info@physisglobalacademy.com

Interested in group enrollment?

Get up to a 50% discount when you sign up for our plans customized for individuals and companies.

You Might Also Be Interested In

Certificate Program in Clinical Trial Project Management

Certificate Program for Clinical Research Coordinator (CRC)

Certificate Program in Medical Writing of Clinical Trial Documents

Certificate Program in Oncology Clinical Trials

Apply discount code EXTRA5 to your cart for an extra 5% discount. Valid until September 28, 2024.

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How To Become A Clinical Research Associate - A New Scientist Careers Guide

• Finding a job
• Career guides

What does a clinical research associate do?

Clinical research associates (CRAs) are responsible for running clinical research, which consists of trials designed to test new or current drugs/immunisations and analyse their effectiveness, risks, benefits and safety of use. 

CRAs play an important role in the healthcare industry and public health development by helping to design and test new medications, vaccinations and other therapeutic agents.

CRAs can be involved at any stage of a drug development trial, including planning, coordinating and supervising. It is their responsibility to ensure a drug has been appropriately examined and all its risks have been evaluated before it is released to be used publicly.

CRAs most commonly work for pharmaceutical companies or contract research organisations. They might also have to spend some time working in a hospital setting to collect data about the drugs they are analysing. They might also work for universities or public/global health organisations. 

As a CRA, you may have a range of responsibilities depending on your employer, project and level of experience. Typically, CRAs will need to complete tasks such as:

• Designing and writing trial protocols and standard operating procedures
• Presenting protocols and procedures to steering committees
• Designing data collection forms
• Requesting ethics approvals and working with ethics committees
• Liaising with staff conducting the trials, such as doctors or consultants
• Training local staff based on trial-specific standards
• Monitoring operations during clinical trial data collection
• Collecting completed data collection forms
• Performing data management and analysis, and discussing the results
• Closing trials and finalising reports with the help of a statistician

CRAs will work in a team of other research professionals, including contract organisation or sponsor staff, principal investigators and clinical research coordinators.

How to become a clinical research associate

To become a CRA, you need to obtain a degree in medical sciences, life sciences or nursing. This can be in subjects such as biomedical science , anatomy, physiology, immunology , pharmacology or broader degree subjects like chemistry and biology .

Alternatively, you can access a career as a CRA by acquiring a higher national diploma (HND). This is a qualification equivalent to the second year of a bachelor’s degree. HNDs can be beneficial to those who want to enter more practical fields, clinical research included.

Occasionally, you can enter a CRA role from an administrative background. For instance, if you begin working as a clinical trials administrator/assistant and decide you would prefer the role of a CRA, you can complete additional qualifications to do this. However, this will take some time and can be difficult.

Most employees view undergraduate qualifications as sufficient, but in some cases a postgraduate degree may be beneficial. Master’s degrees and PhDs can gain you an advantage when applying for competitive positions, and help you gain more experience in research .

Work experience is key to securing a clinical research job. You can get this at any point in your training, and some universities may help with this. The types of work experience most useful for a CRA role include:

• Academic research
• Pharmaceutical research (e.g. via a pharmaceutical industry placement during your degree)
• Laboratory work
• Nursing or care work
• Work in a pharmacy or medical sales
• Other, similar activities

How long does it take to become a clinical research associate?

Becoming a CRA will usually take around three to four years, depending on the access pathway you choose.

If you opt to complete an undergraduate degree, this can take three to four years. You can then apply to job positions as a CRA straight away. However, if you don’t have sufficient work experience, you may need to start at a lower-level position such as a more administrative job. From here, you can gain more experience and reapply for a higher-level position.

If you choose to obtain a HND qualification, this will take two years. Provided you have sufficient experience, you can then apply for a graduate post as a CRA, but again you may need to gain some extra experience/qualifications in some cases.

If you opt to do a postgraduate degree first, this may take an additional one to three years depending on whether it is a master’s degree or a PhD. Many CRA job positions also allow for completion of postgraduate qualifications alongside the job.

A day in the life of a clinical research associate

Most CRAs work about 40 hours a week, during weekdays. There may be an out-of-hours commitment, for instance if working in a hospital setting monitoring a new drug, but this is dependent on your employer and role.

CRAs can work on multiple trials at a time, in multiple different sites. This will depend on the complexity of each trial and what stage each of the trials is in. Therefore, the role may entail some travelling at times, while other times most of your work will be concentrated on one site.

As a CRA, you will carry out a wide variety of tasks. Some days may be spent writing reports. On other days, you will work on site with healthcare staff , or you might go into your office and attend meetings.

No matter your experience level or how senior your role is, as a CRA, you will need to work in a team with other research and healthcare professionals. You will be communicating with research nurses, doctors, health consultants, investigators and managerial and administrative staff from the company requesting the trial.

The role requires good communication skills, as well as good time management and organisation skills, because carrying out a few different studies at once may mean some tasks clash with one another and you need to prioritise the most important ones.

Clinical research associate: Career options

As with most clinical roles, CRAs undergo lots of continuing professional development (CPD) within their role. There are many training courses available to CRAs to build on their existing skills and develop new competencies.

Most training courses are organised by external bodies, and many are paid for by the employer. One of the organisations that runs training courses is the Institute of Clinical Research (ICR). It provides training in areas such as effective project management for clinical trials and advanced clinical trial monitoring, among several others.

The ICR also offers certificates and a diploma that you can complete to evidence your skills in clinical research. Becoming an ICR member and obtaining courses and qualifications from it can also be beneficial to career development, as you will meet other prominent professionals in your field through interacting with this organisation.

You can also opt to complete a postgraduate qualification, such as a PhD or master’s degree in several different areas, including clinical research and clinical pharmacology .

As mentioned, you may need to climb up the professional ladder to become a CRA, and many people start off as clinical trial administrators or junior CRAs. Within these roles, you might complete tasks such as handling documentation and correspondence or helping to set up trial sites. 

From here, you can move on to becoming a senior CRA as you gain experience. At this point, you will have more advanced responsibilities, such as project management of whole trials and designing case report forms.

If you develop sufficient experience and gain contacts in the field, there is a possibility of self-employment if you want to become a freelance CRA. 

Salary: How much does a clinical research associate earn in the UK and US?

In the UK, starting salaries for CRAs range between £26,000 and £34,000 per year. As a more senior CRA, you might earn between £35,000 and £50,000, and in the most senior positions involving managerial tasks, you might earn upwards of £55,000.

Salaries will vary between regions and employers, as well as depending on your level of experience and responsibilities. Some companies offer additional benefits.

In the US, the average salary for a CRA is $70,000 per year. The range is between $60,200 and $80,900. This can vary depending on the region you work in, your education and experience levels and any additional qualifications you have.

Salaries will also be different as a freelance CRA, and this will depend on the number of clients you have and any business-related expenses you need to cover.

• Prospects. Clinical research associate. Available from: https://www.prospects.ac.uk/job-profiles/clinical-research-associate (accessed Apr 2024)
• CK Group. Clinical research associate (CRA) job profile. Available from: https://ckgroup.co.uk/candidate/job-profiles/clinical-research-associate-cra-job-profile/ (accessed Apr 2024)
• Nikolova, T. The CRA Wizard. How to become a CRA for dummies in 7 steps (or less). Available from: https://www.thecrawizard.com/how-to-become-a-cra-for-dummies (accessed Apr 2024)
• Glassdoor. Clinical research associate career. Available from: https://www.glassdoor.co.uk/Career/how-to-become-clinical-research-associate_KO14,41.htm (accessed Apr 2024)
• Coursera. How to become a clinical research associate. Published Nov 2023. Available from: https://www.coursera.org/articles/clinical-research-associate
• Walters, L. Pharmiweb.jobs. 8 ways to advance your career as a clinical research associate (CRA). Published Sept 2023. Available from: https://www.pharmiweb.jobs/article/8-ways-to-advance-your-career-as-a-clinical-research-associate-cra- (accessed Apr 2024)
• Salary.com. Clinical research assistant salary in the United States. Available from: https://www.salary.com/research/salary/alternate/clinical-research-assistant-salary (available from Apr 2024)

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Clinical Research Associate 1

• Science and Medical Research
• Opening on: Sep 26 2024
• Cancer Center-Administration
• Research Foundation
• Clinical Research Associate I, E99

Job Summary:

The Clinical Research Associate I will coordinate Oncology research trials for the Cancer Center and associated satellite sites, primarily involving investigational medications and treatments, including early or late phase FDA-regulated trials. Ensure compliance with federal guidelines at every step. Interact and correspond with clinicians, sponsors, cooperative groups, Upstate's Institutional Review Board and regulatory agencies. Enroll, register and screen patients for Oncology clinical research trials; collect and submit clinical trial patient data. Perform various administrative duties, which may include proper collection and shipment of lab samples; regulatory upkeep and maintenance of clinical research study supplies.

Minimum Qualifications:

Bachelor's degree and 2 years related experience or equivalent combination of education and experience. Excellent oral and written communication skills and attention to detail. Ability to work both independently and within a team setting.

Preferred Qualifications:

SoCRA or ACRP certification or Oncology research experience

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