clinical research associate qualifications australia

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I’ve attended quite a few PRAXIS workshops now. The content across the workshops I’ve attended has always been presented in clear and accessible ways, and I always come away with a sense of how I can utilise that information in my role. Alison Harwood, Research Ethics Officer, The University of Adelaide

The whole [HREC] course was extremely valuable and provided a lot of useful information and perspectives that certainly helped to broaden my understanding of the role of HRECs. Kerry, Lawyer, Australian Institute of Sport Ethics Committee

PRAXIS Australia is a leading Australian and International NFP education and training provider. Our training offers are built upon the competencies developed by the Harvard Multi-Regional Trials Centre (MRCT) and aligned to competencies recommended by the NHMRC.

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Ensuring Effective Project Management

26 September 2024, 10.00am – 2.00pm

Packed with tips and strategies, you’ll discover the techniques you need to manage your projects successfully and methodically.

Consumer Engagement in Clinical Trials

1 October 2024, 10.00am – 2.00pm

Explore techniques to amplify the voices of consumers while fostering a collaborative environment that drives meaningful impact.

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15 October 2024, 10.00am – 2.00pm

Join us to learn new skills and ensure that you chair committees and their meetings most effectively and efficiently. Your organisation and your team will thank you.

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24 October 2024, 10.00am – 2.00pm

For clinical staff and managers to learn business concepts by developing core competencies they can use in growing a successful clinical trials unit.

Good Clinical Practice

31 October 2024, 10.00am – 2.00pm

Understand the importance of research conduct and why following GCP leads to excellent science, quality data, reducing risk and keeping participants safe.

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7 November 2024, 10.00am – 2.00pm

Suitable for those working across the development lifecycle of Medical Devices including regulators, industry, researchers, research site staff and HREC and governance.

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Building the pipeline of future medical, nursing, midwifery, and allied health clinician researchers

The university of queensland/metro north hospital and health service clinician researcher training pathway (crtp) – inaugural intake.  .

Strengthening Australian clinical research through the identification, training, and support of our future medical, nursing, midwifery, and allied health research leaders.

The inaugural Clinician Researcher Training Pathway (CRTP) brings together The University of Queensland and Metro North Hospital and Health Service (Metro North Health). It is designed to train and support future medical, nursing, midwifery, and allied health research experts through a structured and mentored pathway that includes time to prepare for and complete a PhD as well as protected time for post-doctoral research.  

Applications are encouraged from Australian citizens and permanent residents who will be employed in Metro North Health from 2023 as registered clinicians, or including for medically-qualified applicants on a specialty training rotation that will bring the doctor to Metro North Health by February 2023.  

Up to four places will be offered as part of the inaugural intake, supported through the award of a stipend of $50,000 per annum*. 

Applications aligned to Metro North Health and UQ strategic imperatives are preferred. Applicants with an interest in surgery and surgical outcomes; infectious disease management and preventions; and cancer control and care are encouraged to apply, noting that CRTP is not restricted to these areas of research. All applicants must satisfy UQ Graduate School entry requirements for admission to Higher Degree by Research programs and must not be currently enrolled in a Doctor of Philosophy (PhD) program. 

Submissions will be accepted until 5pm AEST on 23 November 2022.  

Short listed applicants will be invited to interview on 6th December 2022.  

* In year 1 of the program the stipend is pro-rated at 50%. During full-time PhD studies, stipend is 100%. Scholarships for full-time students are generally not considered income for tax purposes, however it is the candidate’s responsibility to check tax implications for their scholarship and personal circumstances. There may be tax implications for part-time scholarships. For advice on whether or not a scholarship is taxable, candidates should use  Is my scholarship taxable? , the Australian Taxation Office’s scholarship decision tool.

About the program

CRTP is a structured, mentored concurrent clinical and research training pathway designed to develop and support our future clinical knowledge translators and innovators. 

The University of Queensland and Metro North Health are in a fortunate position to be leveraging the work that the Go8 Deans of Medicine and MACH-Track have undertaken, which includes gaining support from specialist colleges and other peak bodies # .  

We are excited to be launching the program for the first time with Metro North Health. Through this initiative we are seeking to ensure our nation has secured future generations of clinician researchers, a driving force in healthcare innovation, working together for a healthier future for all. Testimonial from Professor Stuart Carney, Dean, Medical School, UQ

The program includes an opportunity to undertake  Doctor of Philosophy (PhD)  program as well as protected time for post-doctoral research. It is designed to enable you to contribute to health knowledge in your field of specialty and gain expertise that is innovative, relevant, and progressive.  

#, For further information of the genesis of this exciting initiative we refer you to recent, relevant submissions and articles, specifically the  Insight Plus article , the  Go8 white paper  to the Medical Workforce Reform Advisory Committee, and the  AAHMS report . 

UQ/Metro North Health CRTP will be attractive to research-minded doctors in training. It provides a clear research higher degree pathway with mentorship from experienced Clinician Researchers without major delays or interruptions to the completion of clinical training. UQ will provide financial support through a higher degree by research stipend and Metro North Health will offer the ability to work clinically throughout their research studies. It is anticipated that there will be protected time for research for up to three years post-PhD completion. 

Intake for the 2023 Metro North Health cohort is now open. The framework integrates research training with vocational training and will run over at least five years:  

Year 0 (2022) : during prevocational or vocational training, medical graduates prepare their application for a place in the cohort.  

Year 1 (2023) : Clinician Research Registrar/Commence PhD – It is anticipated that Metro North Health will employ the carefully selected Clinician Research Registrar at 0.8FTE allowing time for part-time PhD enrolment. UQ will offer a part-time living stipend and tuition fee scholarship.  

Years 2-4 (2024-2026) : Full-time PhD enrolment – The candidate will undertake the PhD project on a full-time basis. UQ will offer a full-time living stipend and tuition fee scholarship as well as a Researcher Development Package to cover travel and professional development activities. It is anticipated that the trainee will maintain an employment relationship with Metro North Health with opportunities to work up to 0.2FTE clinically.  

Year 5+ (2027+) : Senior Clinician Research Registrar – As the Senior Clinician Research Registrar works towards completing clinical training, it is anticipated that Metro North Health will provide 0.2FTE protected research time. This will enable the trainee to defend their thesis (essential for progression to year 6), publish papers and apply for external funding. It is anticipated that up to three years of 0.2FTE protected research time will be offered while the trainee completes specialty training. 

Independent Clinician Researcher : Although not guaranteed, we would hope that those who complete the pathway are able to secure a consultant-level appointment with Metro North Health including an academic appointment with UQ. 

Pre-application enquiries 

Medically qualified applicants must be on a vocational training program approved by the relevant Royal/Specialist College that will bring them to Metro North Health by February 2023. For specialties with two stage programs (e.g., RACP) trainees should ideally have secured a place in an advanced training program. Potential medically-qualified candidates concerned about eligibility should provide details of future position/s appointments in their relevant specialist college vocational training program. 

Submit pre-application enquires to [email protected] .

Need help identifying your Metro North Health Research Strategy aligned project? 

The Metro North Health Research Strategy refresh is underway and provides an opportunity to set a collective vision of research excellence, to build on our strong culture of research to deliver exceptional health outcomes through globally recognised discovery and translation.  

The inaugural Metro North Health Research strategy (2017-2022) outlines three main themes to encourage collaboration and excellence across the research continuum. The themes are achieving excellence in diagnostics, therapeutics, and health services research. 

To identify aligned projects and find a Metro North Health-based supervisor for your advisory team contact your clinical manager, department manager or director (as appropriate) or the Metro North Office of Research via [email protected] or 3647 9631.

Your Metro North Health-based supervisor can be your Principal or Associate Advisor for your PhD. As a Principal Advisor, they will need to hold an appropriate UQ appointment. You will also need to identify a UQ-based advisor. 

Do you need help finding a UQ-based advisor for your project? 

The Faculty of Medicine is tackling complex medical problems that represent global challenges to human health. Medical and biomedical science research projects within the Faculty have already led to discoveries with far-reaching social and economic impacts, including the Gardasil vaccine for cervical cancer. 

Explore our research

Find UQ-based researchers in your area of interest  

Have questions? Submit pre-admission enquiries to [email protected]     

Ready to apply? 

We encourage applications from medically qualified research-minded individuals with a passion to pursue a career as a clinician researcher and who are eager to assume a role as one of the future leaders of clinical innovation in Australia.  

Nurses and midwives

UQ/Metro North Health CRTP will be attractive to research-minded nurses and midwives. It provides a clear training pathway of clinical development, research training, and mentorship from experienced Clinician Researchers. We will provide financial support, through a higher degree by research stipend and Metro North Health will offer the ability to work clinically throughout their research studies. It is anticipated that there will be protected time for research for up to three years post-PhD completion. 

Intake for the 2023 Metro North Health cohort is now open to nurses and midwives employed at Metro North Health. The framework integrates research training with clinical development and will run over at least five years:  

Year 0 (2022) : Nursing and midwifery candidates who have completed at least two years of employment since graduating prepare their application for a place in the cohort. 

Year 1 (2023) : Clinician Researcher / commence MPhil or PhD, depending on previous research qualification/experience. For those without the requisite research qualifications/experience, it is anticipated that Metro North Health will employ the carefully selected Clinician Researcher nurse or midwife 0.5FTE, allowing for part-time MPhil enrolment. UQ will offer a part-time living stipend and tuition fee scholarship. During MPhil candidature, candidates seek to transfer to the PhD program through UQ’s Progress Review process at the end of year 1. For those with suitable research qualifications/experience, it is anticipated that Metro North Health will employ the carefully selected Clinician Researcher nurse or midwife 0.8FTE, allowing for part-time PhD enrolment. UQ will offer a part-time living stipend and tuition fee scholarship. 

Years 2-4 (2024-2026):  Full-time PhD enrolment – The candidate will undertake the PhD project on a full-time basis. UQ will offer a full-time living stipend and tuition fee scholarship as well as a Researcher Development Package to cover travel and professional development activities. It is anticipated that the Clinician Researcher will maintain an employment relationship with Metro North Health with opportunities to work up to 0.2FTE clinically. 

Year 5+ (2027+) : It is anticipated that Metro North Health will provide 0.2FTE protected research time. This will enable the Clinician Researcher to defend their thesis (essential for progression to year 6), publish papers and apply for external funding. It is anticipated that up to three years of 0.2FTE protected research time will be offered as part of the pathway. 

Independent Clinician Researcher : Although not guaranteed, we would hope that those who complete the pathway are able to secure a clinician-researcher appointment with Metro North Health including an academic appointment with UQ.   

The Faculty of Health and Behavioural Sciences is at the forefront of innovation in health education and research. Our research is interdisciplinary, applied, intensive and, world leading.  

Find UQ-based researchers in your area of interest

We encourage applications from high potential, research-minded individuals with a passion to pursue a career as a clinician researcher and who are eager to assume a role as one of the future leaders of clinical innovation in Australia.  

Allied health

UQ/Metro North Health CRTP will be attractive to research-minded allied health clinicians. It provides a clear training pathway, minimal delays to the completion of clinical training, and mentorship from experienced Clinician Researchers. We will provide financial support, through a higher degree by research stipend and Metro North Health will offer the ability to work clinically throughout their research studies. It is anticipated that there will be protected time for research for up to three years post-PhD completion. 

Intake for the 2023 Metro North Health cohort is now open to allied health practitioners employed at Metro North Health. The framework integrates research training with advanced practice and development and will run over at least five years:  

Year 0 (2022) : allied health candidates who have completed at a minimum their graduate year prepare their application for a place in the cohort. 

Year 1 (2023) : Clinician Researcher / commence MPhil or PhD, depending on previous research qualification/experience. For those without the requisite research qualifications/experience, it is anticipated that Metro North Health will employ the carefully selected Clinician Researcher 0.5FTE, allowing for part-time MPhil enrolment. UQ will offer a part-time living stipend and tuition fee scholarship. During MPhil candidature, candidates seek to transfer to the PhD program through UQ’s Progress Review process at the end of year 1. For those with suitable research qualifications/experience, it is anticipated that Metro North Health will employ the carefully selected Clinician Researcher 0.8FTE, allowing for part-time PhD enrolment. UQ will offer a part-time living stipend and tuition fee scholarship.  

Years 2-4 (2024-2026) : Full-time PhD enrolment – The candidate will undertake the PhD project on a full-time basis. UQ will offer a full-time living stipend and tuition fee scholarship as well as a Researcher Development Package to cover travel and professional development activities. It is anticipated that the Clinician Researcher will maintain an employment relationship with Metro North Health with opportunities to work up to 0.2FTE clinically.  

Year 5+ (2027+) : Post-PhD - It is anticipated that Metro North Health will provide 0.2FTE protected research time. This will enable the Clinician Researcher to defend their thesis (essential for progression to year 6), publish papers and apply for external funding. Up to three years of 0.2FTE protected research time is anticipated as part of the pathway. 

Submit pre-admission enquires to [email protected] . 

To identify aligned projects and find a Metro North Health-based supervisor for your advisory team contact your clinical manager, department manager or director (as appropriate) or the Metro North Office of Research via [email protected] or 3647 9631  

Important dates

For the 2023 uq/metro north health crtp intake: .

Mid-October 2022 : Applications open 

23 November : Applications close at 5pm (AEST) 

By 30 November 2022 : Notification to short-listed applicants 

6 December : Short-listed candidates are interviewed  

Mid-December : Successful candidates are offered a place in the program and commence UQ Graduate School online application 

By 29 January 2023 : successful applicants complete UQ Graduate School online application 

April 2023 : Candidates commence their concurrent training program 

Mon – Fri | 9 AM – 5 PM | AEST

[email protected]

1300 39 22 06

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Clinical Research Associate Foundation

Why become a clinical research associate (cra).

Clinical research is one of the fastest growing industries globally at 6-8% increase every year. The global CRA talent pool grows by about 4-5% and provides great career opportunities. For anyone starting new in the industry, now is the time as 1 out of 4 CRA hires is an early talent and the number of early talent opportunities is growing.

Starting CRA salaries are from about AU$70,000 in Australia, €35.000 in Europe, and US$75.000 in the USA. Next to great starting salaries there are fast career pathways, promotions to come within 2-3 years into professional levels, taking salaries up to AU$130,000 in Australia (excluding bonuses), €45.000 in Europe, and US$95.000 in the USA.

If you have prior qualifications in STEM/Health, you have a good chance of entering this industry as a CRA.

Why choose Clueo Clinical Industry Foundation?

Upon successful completion of this program, you will have all the competencies to enter the industry as Clinical Research Associate (CRA).

What you’ll learn

You will gain the following essential knowledge and skills in our CRA Industry Foundation:

Who is this program for?

This program is ideal for anyone with little to no experience, who is interested in becoming a clinical research associate (CRA) (also known as study monitor or clinical site manager [CSM]).

Requirements

Minimum prerequisite: Tertiary education in a related science or health care discipline.

No prior clinical research experience is necessary to commence this course. It is advantageous, however, if you already have 1-2 years of work-experience in a health- or science-related industry.

The Industry Foundation can be completed in approximately 3-4 months. However, you’ll have up to 365 days from program commencement to complete.

Course Delivery

The Industry Foundation is a self-paced virtual training program thoughtfully designed to tailor to your own individual learning style(s). This means you can complete the program anywhere, at anytime.

Please note: Our virtual live on-demand tutorials facilitated by Industry Experts are only available at specific scheduled times.

Certification

• To obtain the  Certified Completion Certificate in CRA Industry Foundation , you will need a score of ≥ 80% to pass all assessments and quizzes.
• You’ll have unlimited chances to take individual module and course quizzes.
• You’ll have ONLY two (2) attempts to take the Final Assessment, which is a 2-hour exam. Failing the initial 2 attempts will result in a minimum 2-month delay before ONE (1) final attempt can be granted, during which we recommend you relearn the course materials that you have not yet mastered.

If you meet these criteria, your  Certified Completion Certificate in CRA Industry Foundation will be awarded after you have successfully passed the Final Assessment.

You have 3 payment options for this program:

How to enroll

To enroll into this program, please click on the ENROLL NOW button below.

More information

If you would like to know more about our Industry Foundation program, please  contact us .

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Patient recruitment and site selection, early phase trials in australia, clinical operations and project management, site management organization (smo), biometrics and data management, virtual clinical trials, real world data, laboratory services, oncology cro services, pharmacometric services, drug development consulting, gmo solutions, liver disease cro services, infectious diseases and vaccines cro services, orphan and rare disease cro services, clinical and regulatory strategy, novotech appoints dr. yooni kim as a new executive position of managing director for apac to….

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We are internationally recognized as a leading regional full-service contract research organization (CRO) in Asia-Pacific providing clinical development services across all clinical trial phases and a broad range of therapeutic areas. We have created a strong benchmark, in the healthcare industry. We are a biotech focused CRO. with strong experience in a broad range of therapeutic areas including:

• Infectious Diseases
• Orphan and Rare Diseases
• Neurology and Psychiatry
• Cardiovascular
• Endocrinology

WHAT IS THE CRA I PROGRAM?

This program will provide the training and mentorship to grow your career as a Clinical Research Associate. Novotech’s CRA I program will equip you with the right site management and monitoring knowledge and skills to manage a clinical project and work alongside seasoned CRAs and Project Managers at Novotech.

This program is designed for professionals who have an education and experience in life sciences. Over 12 weeks, our CRA Essentials program is a combination of self-learning and instructor-led engagement to cover in-depth GCP and trial management learning modules with hands-on practical sessions and observation visits to build know-how and proficiency.

At the completion of the 12-week program, CRAs are assigned to projects and will continue to be mentored by our unique NovoBuddy program, Line Manager and experienced CRAs.

WHAT WILL HELP YOU SUCCEED IN THE CRA I PROGRAM?

• Your experience in the life sciences sector and knowledge of the pharmaceutical/research/ clinical trial industry will be offer advantage of familiarity with the business, research processes and interaction with customers and Investigators.
• A commitment to ongoing learning and development is essential and Novotech supports all Team Members to reach their career and personal goals.
• A passion for clinical research and improving patient outcomes.

HOW TO SUBMIT A GREAT APPLICATION

• About why you want to work in clinical trials; and
• Why you would be a great addition to our Clinical Operations Team.
• An overview of your degree and study areas; and
• A summary of your work experience including any internships related to clinical trials, academic research, pharmaceuticals or similar
• Submit your application via the Novotech Careers website here

Please note that this intake is for candidates currently located in Australia or New Zealand with full working rights. The CRAI intake in Asia will be open in early 2022.

OTHER OPPORTUNITIES AT NOVOTECH

Novotech also offers a variety of opportunities to join the clinical research industry, please follow us on LinkedIn for updates or check our careers site in early 2022.

• CRAI Program intake for Asia will be in March 2022, with applications open in January.
• Starting as a Clinical Trial Administrator (CTA) is a great first step into clinical research. New opportunities for CTA’s will be open in early 2022.

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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/strategy/people-and-culture

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook https://www.novartis.com/careers/benefits-reward

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 to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://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.

• 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

33RD ANNUAL CONFERENCE

ACHIEVING EXCELLENCE IN CLINICAL RESEARCH :

FORGING STRATEGIC COLLABORATIONS

September 27 to 29

COUNTDOWN TO ANNUAL CONFERENCE

Join us for expert-led sessions, interactive workshops, a peer-driven poster program, an engaging exhibit program and unparalleled networking opportunities!

Graduate Coursework

Graduate Certificate in Clinical Research

• Course code: N12AA

Course overview

Advance your career in clinical research. If you are a medical, biomedical, nursing or allied health professional, our graduate programs provide you the opportunity to develop a broad understanding of the discipline and practice of research in a clinical context.

The Graduate Certificate will teach you how to design a clinical research study, including quantitative and qualitative methodology, evaluation of research literature, statistical analysis and ethics in clinical research.

Flexible study and international student pathways

Both part-time and full-time study options available. The Graduate Diploma and Master awards are available to international participants.

International students are welcome to study this course. However, please note that this course is not available to international students who require a student visa to study in Australia as it does not meet the onshore study requirements and it is not registered with CRICOS.

Begin your clinical research career

You can progress from the Graduate Certificate to the Graduate Diploma and finally the Master of Clinical Research, or apply directly to the Graduate Diploma and Master awards. The Master of Clinical Research satisfies the 25 point research pathway to PhD admission.

Research excellence and networks

Led by some of the finest and well regarded clinical researchers at one of the world’s premier research universities.

Related pathway courses

• Master of Clinical Research
• Graduate Diploma in Clinical Research
• Specialist Certificate in Clinical Research (Neuroscience) .-->