Senior Clinical Research Associate - France
Location: London (Preferably located close to Dijon, France)
Job Category: Clinical Research / Monitoring
Time Type: Part-time (0.2 FTE)
Posted on: 4 Days Ago
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About ProPharma:
ProPharma has been at the forefront of advancing patient health for over 20 years, empowering biotech, pharmaceutical, and medical device organizations of all sizes. Through a comprehensive advise-build-operate model, ProPharma provides customized solutions that drive successful drug and device programs, de-risking and accelerating their journey through the product lifecycle. ProPharma's services span across regulatory sciences, clinical research, pharmacovigilance, and R&D technology, ensuring clients receive expert guidance at every step.
Position Overview:
ProPharma is seeking an experienced Senior Clinical Research Associate (CRA) to join our global team. This role will be part-time (0.2 FTE) and based in France, preferably near Dijon. The CRA will be responsible for conducting all types of monitoring and site management activities for clinical trials, including remote and in-person visits, site initiation, interim, and close-out monitoring.
Essential Functions:
Conduct monitoring visits and co-monitoring for clinical sites, including site initiation, interim, and close-out visits.
Prepare and complete monitoring reports in accordance with SOPs and local regulatory parameters.
Perform study start-up activities, such as site identification, feasibility activities, preparation of essential documents, and Ethics Committee submissions.
Develop and maintain monitoring-specific documentation, including monitoring trackers, clinical monitoring plans, and source document templates.
Train site personnel on protocol requirements, proper source documentation procedures, and case report form (CRF) completion.
Review source documents and CRFs for accuracy and completeness, resolving data issues as needed.
Manage investigational supplies, ensuring proper dispensing, inventory, and reconciliation.
Monitor clinical trials, providing regular updates on enrollment, protocol deviations, adverse events, and other activities critical to trial conduct.
Oversee and review regulatory documentation for accuracy and completeness.
Communicate regularly with site personnel, investigators, and other team members to ensure proper study execution.
Participate in meetings and conference calls with internal and external stakeholders.
Perform other duties as assigned.
Necessary Skills and Abilities:
Excellent verbal, written communication, and interpersonal skills.
Strong computer skills, particularly with Microsoft Office (Word, Excel, PowerPoint, Outlook).
Experience with electronic data capture (EDC), CTMS, IVRS, and eTMF systems.
Knowledge of local laws, regulatory requirements, ICH Guidelines, and GCPs for clinical trials.
Ability to prioritize tasks, plan proactively, and work with minimal supervision.
Strong organizational skills and attention to detail, with the ability to manage multiple tasks effectively.
Ability to offer solutions when obstacles arise and provide necessary training to achieve project goals.
Educational Requirements:
Bachelor’s degree or equivalent combination of education and experience.
Experience Requirements:
A minimum of 5 years of experience as a Clinical Research Associate.
Workplace Commitment:
ProPharma embraces diversity and inclusion, encouraging employees to be their authentic selves. We are committed to fostering an environment where innovative and entrepreneurial spirits thrive. As an Equal Opportunity Employer, we provide a safe space for all employees to succeed.
Additional Information:
ProPharma does not accept unsolicited resumes from recruiters or third-party agencies.
No phone calls or emails regarding this posting, please.
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