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Found 13 jobs

Unblinded cra / pharmacy cra - sponsor-dedicated.

• Malmaison, France
• Competitive

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortre...

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Senior Clinical Research Associate

• France;Homeworking

We are looking for passionate professionals with solid experience as CRAs to work as Senior CRA for onsite monitoring visits in Chile Your time her...

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Attaché de Recherche Clinique - Sponsor dédié en Oncologie

• Syneos Health

Rejoignez une entreprise qui change la donne et réinvente la façon dont les thérapies sont développées et commercialisées. Créés grâce à la fusion...

View details Attaché de Recherche Clinique - Sponsor dédié en Oncologie

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Senior Clinical Research Associate - Paris, Lille or Nice, France - FSP

Parexel is currently seeking Senior Clinical Research Associates in France. These will be home-based positions and fully dedicated to a single spon...

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Clinical Research Associate II - Paris Region, France - FSP

Parexel is currently seeking a Clinical Research Associate II in France. This will be a home-based position and fully dedicated to a single sponsor...

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• France, Homeworking

Senior CRA - RWE ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environmen

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Stage d'Associé de Recherche Clinique - Basé à Paris

L’activité de IQVIA département Sponsor Dédié (FSP) est unique. Nos équipes sont dédiées à un partenaire sponsor unique, dont l’objectif commun

View details Stage d'Associé de Recherche Clinique - Basé à Paris

• 11 days ago
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CRA in Oncology - Home Based in Clermont Ferrand - Sponsor dedicated

• France; Homeworking

Here at Syneos Health, we are looking for a CRA II to work sponsor dedicated to a Top Pharma. You will have the chance to work in exciting Phase II...

View details CRA in Oncology - Home Based in Clermont Ferrand - Sponsor dedicated

• 13 days ago
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Clinical Research Associate II or Senior CRA

CRA II - France, Paris ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive envi

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• 4 days left
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InHouse CRA

InHouse CRA - Officebased in Paris or Lyon Only. ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud t

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Clinical Research Associate France

Clinical Research Associates - France ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an

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Senior CRA dedicated to Sponsor - Paris

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Clinical Research Associate with oncology - Sponsor dedicated (Paris)

View details Clinical Research Associate with oncology - Sponsor dedicated (Paris)

• Expiring today
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Freelance Clinical Research Associate (CRA) - France

Akrn scientific consulting.

Job description

JOB SUMMARY

This is a Freelance position (0,2 - 0,8FTE) for a clinical trial project based in France. Under the direction of the Director of Clinical Operations, the Sr. CRA will implement and coordinate assigned projects, pre-market trials, and post-market registries. The CRA will perform the job according to intern SOP and external requirements. 

KEY RESPONSIBILITIES

• Develop clinical research strategies and clinical trial protocols with the support of external advisors/consultants, as applicable. 
• Managing all aspects of submissions to the locals' Ethics Committees; clinical trial contract negotiations; Patient Informed Consent (PIC) development, case report form (CRF) design and implementation.
• Strong knowledge of local clinical sites and Ethics Committees.
• Database management (data collection, review, and query).
• Maintaining close contact with the local study site coordinators and investigators.
• Leading the clinical team to successfully drive clinical studies under appropriate quality standards, including ICH/GCP, ISO, MDD, MDR, and applicable global regulations, along with company compliance requirements. 
• Lead clinical scientific discussions with local regulatory agencies, investigators, and clinical key opinion leaders (KOL).  
• Drives setting of team goals and milestones; monitors progress.
• Develop and maintain relationships with investigators, coordinators, and site staff.
• Provide project/study management and monitoring plans for projects.
• Safety analyses and safety assessments (or appoint designee).
• Write and review publications which originate from the clinical activities (or appoint designee).

 QUALIFICATIONS/REQUIREMENTS  

• This person needs to be based in France, knowledgeable in French sites. (Mandatory)
• This person must have more than 5 years of past experience as a CRA. (Mandatory)
• Demonstrable experience in clinical trials and monitoring. (Mandatory)
• Medical device experience. Proficient knowledge of cardiovascular medical terminology. Advanced knowledge of clinical and outcomes research study design. (Mandatory)
• Experience as a Clinical Research Consultant. (Mandatory)
• Experience with Medical Devices. (Class-III Devices is preferred)
• Computer proficiency (Microsoft® Office). 
• Good communication and organizational / time management skills.
• Self-motivation with the ability to work under pressure to meet deadlines.
• Detail and process-oriented, positive attitude and approach, multi-tasking capability.
• Working knowledge of FDA regulation/ ICH guidelines / local regulations / ISO14155 regulations, device development, and clinical monitoring procedures.
• Bachelor's degree in life sciences.
• Advanced degree (Masters or PhD) preferred.
• French Speaker. (Mandatory)

Send an email with your CV and coverletter to [email protected]

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• GlaxoSmithKline
• National Cancer Institute (NCI)
• Cairo University
• AstraZeneca
• Assistance Publique - Hôpitaux de Paris
• Mayo Clinic
• M.D. Anderson Cancer Center
• Novartis Pharmaceuticals
• National Institute of Allergy and Infectious Diseases (NIAID)
• Massachusetts General Hospital
• National Taiwan University Hospital
• Boehringer Ingelheim
• Hoffmann-La Roche
• Merck Sharp & Dohme LLC
• Stanford University
• University of California, San Francisco
• Eli Lilly and Company
• Duke University
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Apply by: 2024-11-05

Sr Clinical Research Associate Contractor (France)

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Sr. Clinical Research Associate Contractor (SrCRA) to join our A-team (remote). As a SrCRA Contractor at Allucent, you will independently control and monitor investigational sites, pro-actively detect issues, provide solutions to ensure clinical studies are performed according to the trial protocol and in compliance with SOPs, applicable regulations, and the principles of Good Clinical Practice.

In this role your key tasks will include:

• Governs highest possible quality standards for trial monitoring activities. 
• Conducts all study tasks in compliance with quality, while preserving efficiency and in alignment to the scope of services and budgeted hours.  
• Monitors activities at clinical study sites to assure adherence to protocol, Monitoring Plan, ICH, GCP, SOPs, and applicable regulations and guidelines: 
• Performs efficient site management in line with study budget.  
• Prepares and submits quality Site Visits Reports and Contact reports. 
• Maintains and updates CTMS in compliance with SOPs and study-specific directives. 
• Acts as Document Owner for collected documents. 
• Conducts co-monitoring as needed. 
• Provides functional assistance to the project team members with administrative, logistical, and practical issues, including the tracking, collection, distribution and filing study documentation (CTMS, TMF). 
• Liaises with project team members and Sponsor to track study progress and milestones. 
• Tracks and supervises collection of ongoing study data for purpose of regular project status reporting within agreed timelines. 
• May review essential documents (GLP) as a 2nd line or Independent Reviewer (IR).  
• May participate in organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project specific CRA training. 
• May perform assessment visits. 
• Represents Allucent in the global medical research community, develop and maintain collaborative relationships with investigational sites and sponsor company personnel. 
• Identifies potential logistical/practical problems and propose solutions / contingency plans, with timeframes for resolution. 
• Acts as the lead contact in case several CRAs involved for a same study in same country. 
• Supervises generation of electronic tracking systems and logs to produce status updates, progress reports and general management of the clinical deliverables when needed. 
• May process and track payments to the Institutional Review Boards (IRB), Ethics Committees (EC), Regulatory Authorities, Investigators and /or vendors including timely notification to finance department, as applicable. 
• May participate in meetings with clients. 
• May support project manager/CTL and project functional leads in the project oversight and management. 
• Supports site staff in preparation for study related site audits and inspections. 
• Where applicable, reports Quality Issues and supports the root cause analysis, writing of and resolution of the Corrective and Preventative Actions. 

Requirements

To be successful you will possess:

• At least five years clinical monitoring experience and/or relevant clinical trial experience. 
• Relevant life science degree / medical / nursing background, or combination of education and experience. 
• Excellent understanding and demonstrated application of Good Clinical Practices and applicable Standard Operating Procedures.
• Strong written and verbal communication skills including good command of English and local language.  
• Representative, outgoing and client focused.  
• Ability to work in a fast-paced challenging environment of a growing company. 
• Administrative excellence   
• Proficiency with various computer applications such as Word, Excel, and PowerPoint required. 
• Effective clinical monitoring skills (all kind of visits mastered).
• Ability to perform travel an average of 8 days on site per month, depending on project needs.
• Demonstrated understanding of applicable medical/therapeutic area knowledge and medical terminology. 
• In-depth knowledge of clinical trials and the critical elements for success in clinical trials. 
• Excellent understanding of the drug development process. 
• Ability to proactively identify and resolve issues in a timely manner. 
• Effective oral and written and presentation communication skills, with the ability to communicate effectively with medical personnel. 
• Effective organizational and time management skills. 
• Ability to manage multiple projects and strong attention to detail. 
• Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and clients. 
• Ability to meet project requirements.  
• Proven flexibility and adaptability. 
• Ability to work in a team or independently and to effectively prioritize tasks.

Disclaimers:

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

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CLINICAL RESEARCH ASSOCIATE

Clinical research associate.

The European Center for Cardiovascular Research (CERC) is a CRO specialized in the design and management of international clinical trials dedicated to cardiovascular diseases.

Chaired by four interventional cardiologists, actors of clinical research for over 20 years, the CERC conducted clinical studies directly in line with the issues of cardiologists practicing in private or public hospitals.

CERC is currently supporting thirty studies for industrial promotions but also manages more than 10 “investigators initiated trials” whose purpose is the treatment of conditions / comorbidities for which there is no satisfactory therapeutic strategy.

CERC is an Entreprise à Mission.

CERC is currently looking for Clinical Research Associates to be involved in international clinical studies.

Job description

– Responsible for site management from initiation to close-out in accordance with study specific procedures, applicable SOPs, and ICH GCP guidelines

– Remote monitoring via e-CRF

– Training and information for investigators and the clinical study

– Privileged contact with investigators centers

– On site monitoring of patient safety (review of SAEs, AEs)

– Generate visit reports in compliance with the monitoring plan

– Update all relevant tracking systems on an ongoing basis

– May assist the Clinical Project Leader in regulatory submissions.

Qualifications

– Excellent interpersonal, verbal and written communication skills – Ability to prioritize multiple tasks and achieve project timelines – Ability to take initiative and work autonomously

– Computer skills (Microsoft Office)  

– A Master or higher graduate degree within a science related field, with a CRA training

– Significant experience in performing a Clinical Research Associate role at least 1 year minimum.

Language Skills

Competent in written and oral English, French, and (mandatory) German or Spanish.

Permanent employment contract.

Position to be filled immediately.

Working conditions

12 reasons for joining us👉 https://www.cerc-europe.org/12-reasons/

INTERESTED ?

COVER LETTER

FreelanceCRA.com

A managed network of senior cras, with previous indication and study type experience, offering local regulatory, site contract and monitoring services, working in direct contact with your project manager, covering 76 countries worldwide, supporting services:, expedite recruitment using clinical trial liaisons, international gcp site audits, on-site co-monitoring, gcp training: presential or on-line, partner programs for training, translations and insurance.

25th of May 2018: FCRA is GDPR compliant

FCRA Network is a managed international network of Senior Clinical Research Associates, Lead Clinical Research Associates, Regulatory Affairs Specialists and Clinical Trial Liaisons for roles commonly referred to as SCRA, LCRA, CRA, COL, RAS, RAM or CTL.

The international Senior Consultants in our network provide local regulatory and monitoring services . In today´s world of tight deadlines and complex regulatory issues, it makes sense to contract and build a team of professional local experts.

We can build a full international team of clinical research professionals on short notice, or supply you anywhere in 40+ countries with a single Senior CRA – selected on indication experience and located close to the clinical sites that need to be monitored.

Our dynamic, multi-lingual and experienced consultants work in direct contact with your Project manager, to keep communication lean and costs down.

Are you a Senior CRA? Join us

Senior cra, ctl or ras learn more.

Freelance professionals have control over their own work situation. In addition they do not increase the headcount of the client´s company, while still creating value for money and adding local experience to a potential or existing project.

FreelanceCRA.com provides support with finding new projects, contract negotiations, budgeting, credit control and billing, so you can focus on what is important: delivering quality work.

Communication and confidentiality are most important, so we provide you with a safe and secure web-based mail- box that can be accessed anywhere, any time.

If you are interested in joining the network and have a minimum of four years experience as a field-based Senior CRA or CTL, or as a Regulatory Affairs Specialist, then we invite you to send us your CV for review.

We would like to thank you for recommending us to your colleagues and employers.

Are you looking for CRAs?

International cro or sponsor learn more.

All our multi-lingual Senior CRAs and CTLs are self-employed, and therefore highly motivated and organised, with at least four years of solid field-based experience. They are contracted per country assignment via FCRA Network S.L.

Without exception, all have considerable experience in feasibility, EC & CA submissions, site management and monitoring of clinical Phase I-IV, observational and medical device trials across a wide range of therapeutic areas.

ICH GCP guidelines are strictly adhered to, and the CRAs will work according to your SOPs. Excellent contacts with sites, Ethics Committees and Regulatory Authorities expedite study set-ups.

Our worldwide network can provide your project with Senior CRAs and CTLs and verified translators.  Contracting local CRAs or CTLs means less travel  costs, in-depth knowledge of local regulatory requirements and good cultural awareness.

Core services: International regulatory and monitoring consultancy

Fcra network provides:.

• Access to an international network of Senior CRAs in 76 countries
• Access to Clinical Trial Liaisons and GCP Auditors & Trainers
• Passive and active candidate search
• Selection based on advanced criteria.
• Templated and bespoke contracting
• Budget creation support
• CRA line management
• Knowledge support and sharing
• E&O and PL insurance for running projects
• CRA specific insurance policy

The CRAs in our network provide:

• Regulatory and site monitoring services for Phase I-IV, medical device and late phase studies:
• Feasibility studies
• Regulatory and EC submissions & amendments
• Site evaluation & contracting
• Site staff training & initiation
• Risk based, remote and on-site monitoring
• Close out visits
• Fast response times & placement
• Industry E&O and PL insurance
• Back-up resources available
• Control cost, time & Budget
• Scale team up & down quickly
• No increase of company headcount
• Reduce travel time and overhead costs

For more information:

Supporting services, gcp auditing & training, co-monitoring, clinical trial liaison, gcp group training.

Clinical Research Associate - Barcelona

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Perks and Benefits

Health and wellness.

• Health Insurance
• Dental Insurance
• Vision Insurance
• Life Insurance
• Short-Term Disability
• Long-Term Disability
• HSA With Employer Contribution
• Mental Health Benefits
• Fitness Subsidies

Parental Benefits

• Adoption Leave
• Birth Parent or Maternity Leave
• Non-Birth Parent or Paternity Leave
• Fertility Benefits
• Adoption Assistance Program
• Family Support Resources

Work Flexibility

• Flexible Work Hours
• Hybrid Work Opportunities
• Remote Work Opportunities

Office Life and Perks

• Commuter Benefits Program
• On-Site Cafeteria

Vacation and Time Off

• Paid Vacation
• Paid Holidays
• Volunteer Time Off

Financial and Retirement

• 401(K) With Company Matching
• Stock Purchase Program
• Financial Counseling
• Performance Bonus

Professional Development

• Tuition Reimbursement
• Access to Online Courses
• Internship Program
• Mentor Program

Diversity and Inclusion

• Employee Resource Groups (ERG)
• Diversity, Equity, and Inclusion Program

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King's College London

Job id: 095085 . Salary: £43,205 - £44,347 per annum, including London Weighting Allowance .

Posted: 07 September 2024 . Closing date: 15 September 2024 .

Business unit: Faculty of Life Sciences & Medicine . Department: Biomedical Engineering .

Contact details: Jorge Cardoso . [email protected]

Location: St Thomas’ Campus . Category: Research .

Back to job search

The School of Biomedical Engineering & Imaging Sciences (BMEIS), part of King’s College London, is driven by a commitment to improve the way healthcare is delivered through the use of advanced engineering. ​

BMEIS is diverse and talented group working across the whole MedTech sector, advancing research, innovation and teaching progress through a shared mission of engineering better health for patients worldwide. ​The school’s state-of-the-art labs and clinical-research facilities are embedded in St Thomas’ Hospital to ensure our research projects are fully aligned with current clinical practice. Long-term collaborations with global MedTech companies and new partnerships with innovative start-ups ensure multiple pathways to translation.

Research at the school is organised into ambitious, large-scale and long-term research projects supported by set of six departments. This diverse infrastructure allows us to combine expertise and apply the latest healthcare concepts to deliver ground breaking results.   ​

About the role

This vacancy is open to internal applicants only.

The Postdoctoral Researcher in Clinical Pathway Modelling will play a pivotal role in an innovative project aimed at advancing the understanding and optimization of clinical pathways in dementia and breast cancer. This position offers a unique opportunity to develop and apply cutting-edge AI-driven models that analyse and predict patient journeys through the healthcare system, with the ultimate goal of improving patient outcomes and streamlining healthcare processes.

The role encompasses two main areas of focus: dementia care pathways and breast cancer pathways. In the dementia component, conducted in collaboration with South London and Maudsley (SLaM) NHS Foundation Trust, the Researcher will analyse ethically pre-approved data to model and optimize the tertiary care phase, particularly within specialized memory clinics. This work will provide crucial insights into factors influencing patient outcomes during this critical stage of care.

For the breast cancer component, the role involves a comprehensive analysis of patient trajectories from primary to tertiary care. This includes examining the entire patient journey, from initial diagnosis in primary care settings, through treatment in secondary and tertiary care, and into survivorship or palliative care. The Researcher will be instrumental in supporting data extraction processes, ensuring that the developed models are informed by high-quality, comprehensive data that captures the full spectrum of patient experiences.

A key aspect of this role is the integration of multimodal data sources, including clinical records, imaging data, laboratory results, and patient-reported outcomes. The Researcher will apply advanced analytical techniques, including causal modelling, to differentiate between correlation and causation within clinical pathways. This work will involve leveraging the Federated Learning and Interoperability Platform (FLIP) to access and analyse linked data across different healthcare settings, ensuring data privacy and security while enabling robust analysis of patient pathways.

Through this multifaceted role, the Researcher will contribute significantly to the development of scalable methodologies for clinical pathway optimization. The insights generated from this research have the potential to transform healthcare delivery, providing data-driven recommendations to clinicians and healthcare policymakers. This position offers the opportunity to work at the forefront of healthcare informatics, applying advanced AI techniques to real-world clinical challenges and potentially improving the lives of patients with dementia and breast cancer.

This is a full time post (35 hours per week), and you will be offered a fixed term contract until 31 March 2026.

To be successful in this role, we are looking for candidates to have the following skills and experience:

Essential Criteria

• PhD awarded in Data Science, Biostatistics, Health Informatics, or a related field, or near completion*.
• Some background in statistical modelling, with experience applying these techniques to healthcare data.
• Proficiency in programming languages such as Python or R, with experience in data analysis libraries and tools.
• Demonstrated experience in working with large or complex data.
• Excellent problem-solving skills and ability to work independently on complex research problems.
• Strong communication skills, both written and verbal, with the ability to explain complex concepts to diverse audiences.

* Please note that this is a PhD level role but candidates who have submitted their thesis and are awaiting award of their PhDs will be considered. In these circumstances the appointment will be made at Grade 5, spine point 30 with the title of Research Assistant. Upon confirmation of the award of the PhD, the job title will become Research Associate and the salary will increase to Grade 6.

Desirable Criteria

• Experience with machine learning/inference techniques and their application in healthcare.
• Familiarity with advanced data analysis techniques and relevant healthcare data regulations.
• Track record of publications in reputable journals or conferences in the field of health informatics or clinical pathway modelling.
• Experience in collaborative research projects involving healthcare institutions.

Downloading a copy of our Job Description

Full details of the role and the skills, knowledge and experience required can be found in the Job Description document, provided at the bottom of the next page after you click “Apply Now”. This document will provide information of what criteria will be assessed at each stage of the recruitment process.

Further information

This post is subject to Disclosure and Barring Service clearances.

We pride ourselves on being inclusive and welcoming. We embrace diversity and want everyone to feel that they belong and are connected to others in our community.

We are committed to working with our staff and unions on these and other issues, to continue to support our people and to develop a diverse and inclusive culture at King's. We ask all candidates to submit a copy of their CV, and a supporting statement, detailing how they meet the essential criteria listed in the advert. If we receive a strong field of candidates, we may use the desirable criteria to choose our final shortlist, so please include your evidence against these where possible.

To find out how our managers review your application, please take a look at our ‘ How we Recruit ’ pages.

Interviews are due to be held in October 2024.

This role does meet the requirements of the Home Office and therefore we are able to offer sponsorship for candidates who require the right to work in the UK.

Clinical Research Associate II

• Location: France
• Categories Clinical Monitoring
• __vacancyopjusttionswidget.opt-Business Area__ ICON Strategic Solutions
• __vacancyopjusttionswidget.opt-Remote Working __ Remote

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About the role, this vacancy has now expired. please see similar roles below....

We are constantly looking for motivated, reliable and dedicated CRAs who can demonstrate at least 12 months independent external monitoring of commercial studies (or a mix of commercial clinical studies) ideally in Oncology and Hematology. Other therapeutic areas are also of interest, especially if gained on phase I - II or III commercial trials.

As a Clinical Research Associate you will be dedicated to one of our global pharmaceutical clients; with whom ICON shares a culture of innovation, flexibility and a common vision of bringing life-improving drugs to market. Leading by example, you can set the standard of excellence and enjoy a challenging career in our exclusive programs.

We are currently looking for a Clinical Research Associate to join one of our sponsor-dedicated teams.

Key responsibilities include: 

• Full ownership of investigator sites for assigned studies with responsibility for the successful management of the site right through to close-out.
• Planning and conducting various site visits (feasibility, site selection, interim and close-out) in accordance with the clinical monitoring plan.
• Developing effective relationships with investigator site staff to ensure that key clinical metrics are met.
• Preparing for and attending investigator meetings, coordinating the timely shipment and the subsequent proper storage and accountability of clinical supplies and following-up of drug safety issues.
• Ensuring integrity of clinical data through an ability to sufficiently maintain site tracking records and work diligently to relevant guidelines.

We believe our Clinical Operations team is second to none. You will receive the support you need to develop personally and professionally and work in an environment where you matter. Our team pushes forward together. United in solving problems, developing close site relationships and reaching the end goal. Operating as a key part of a global study team, the CRA plays a fundamental role in our clients’ drug development processes.

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