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AI Summary
The role involves monitoring clinical trials through site visits to ensure protocol and GCP compliance. Responsibilities include managing investigational sites, verifying clinical data accuracy, and providing training to site staff.
Fortrea is recruiting!
Our FSP department in Paris is looking for a Senior Clinical Research Associate II (SCRAII).
Key Responsibilities:
Monitor Clinical Trials - conduct site visits to ensure compliance with protocols, regulatory requirements and Good Clinical Practice (GCP) - National on sites visits in France (40%).
Site Management - Serve as the primary point of contact for investigational sites, ensuring smooth study operations.
Source Document Verification (SDV)- Review and verify accuracy of clinical data collected from study sites.
Investigator Training and Support - Provide ongoing training to site staff on study protocols and regulatory requirements
Reporting and Documentation - Prepare monitoring reports, maintain study records, and contribute to overall trial documentation.
Qualifications:
Life Sciences University degree or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). (Fortrea may consider relevant and equivalent experience in lieu of educational requirements)
Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.
Thorough knowledge of monitoring procedures and basic understanding of the clinical trial process.
Fluency in English, written and verbal.
What We Offer:
Office based or remote position
Career growth environment in a supportive environment
Dedicated Line Manager
Works directly with a leading sponsor on innovative studies
Attractive salary and Fortrea benefits
If you are passionate about clinical research, thrive in a collaborative environment, and seek exciting career growth, we want to hear from you!
Learn more about our EEO & Accommodations request here.
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