Clinical Research Associate I – FSP (France)

About the role

We are looking for a Clinical Research Associate I (CRA I) to join our global team and support clinical monitoring activities across France. You will work on both remote and on‑site visits, ensuring that investigational sites comply with the protocol, ICH‑GCP guidelines and sponsor requirements.

Key responsibilities

• Conduct risk‑based monitoring visits (remote or on‑site) to assess protocol and regulatory compliance.
• Perform source data verification (SDV), source data review (SDR) and CRF review to ensure data accuracy.
• Assess investigational product inventory and documentation.
• Document observations, prepare monitoring reports and letters, and escalate deficiencies to clinical management.
• Maintain regular communication with sites to resolve identified issues and confirm timely data entry.
• Participate in investigator payment processes and investigator meetings.
• Assist in site initiation, trial close‑out, and retrieval of trial materials.

Required profile

• Strong understanding of clinical trial monitoring and site management processes.
• Ability to apply root cause analysis, critical thinking and problem‑solving skills.
• Excellent written communication for timely reporting.
• Detail‑oriented with a focus on audit readiness and regulatory compliance.

Required skills

• ICH‑GCP guidelines
• Root cause analysis (RCA)
• Source data verification (SDV)
• Source data review (SDR)
• Clinical trial monitoring tools