CRA in Oncology - Sponsor dedicated - Based in Paris Area

CRA in Oncology – Sponsor Dedicated – Based in Paris Area

Based in the Paris Area, this clinical research associate role focuses on oncology studies with a sponsor dedicated engagement. The position is responsible for ensuring compliance with regulatory, ICH‑GCP, and Good Pharmacoepidemiology Practice (GPP) standards throughout the study lifecycle.

Responsibilities

• Perform site qualification, initiation, interim monitoring, site management, and close‑out visits, ensuring regulatory and protocol compliance.
• Verify informed consent procedures and maintain subject confidentiality; assess safety factors impacting clinical data integrity.
• Conduct source document reviews, query resolution, and support electronic data capture compliance.
• Manage investigational product inventory, reconciliation, and storage safety.
• Review Investigator Site File accuracy and reconcile with Trial Master File.
• Document activities through letters, logs, and reports and support recruitment, retention, and awareness strategies.
• Plan and manage site‑level activities, adjust priorities, and ensure deliverables are met.
• Serve as primary liaison with site personnel and coordinate with Central Monitoring Associate.
• Attend investigator meetings and sponsor interactions; support audit readiness and follow‑up.
• Support real world late phase studies, chart abstraction, data collection, and junior staff training.
• Identify and communicate out‑of‑scope activities to Lead CRA/Project Manager; recommend potential sites based on local knowledge.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
• Knowledge of Good Clinical Practice (GCP) and ICH guidelines and applicable regulations.
• Proficient computer skills and ability to adopt new technologies.
• Excellent communication, presentation, and interpersonal skills.
• Ability to manage required travel of up to 75% on a regular basis.
• US ONLY: As part of your employment with Syneos Health, you may be deployed to sites that require certain medical and other personal information to gain facility access; compliance with privacy notices is required.

Additional Information

Tasks, duties, and responsibilities listed in this description are not exhaustive. The Company may assign other tasks at its discretion. Equivalent experience, skills, or education will also be considered.

Summary

Roles within Clinical Monitoring/CRA oversee the integrity of clinical research studies, conducting remote monitoring, utilizing data analytics, and collaborating with site teams to enhance quality monitoring and overall success of trials.