Clinical Research Associate (Level I or II) - FSP - Paris, Lyon, Bordeaux
Core
Coordinate clinical monitoring and site management to ensure trials comply with protocols, ICH-GCP guidelines, and regulations, guaranteeing subject rights and data reliability.
Role type
Clinical Research Associate (Level II)
Builds
Clinical trials for pharmaceutical and biotech sponsors
Domain
Life Sciences / Clinical Research
Required skills
Clinical monitoring, Risk Based Monitoring (RBM), Root Cause Analysis (RCA), Protocol compliance, ICH-GCP knowledge, Site initiation, Data review (SDR/SDV/CRF), Investigational product inventory, Regulatory audit response
Preferred skills
Medical/therapeutic area knowledge, French fluency, English proficiency, Microsoft Office
Technologies
Clinical Trial Management Systems (CTMS), Microsoft Office
Responsibilities
Conduct on-site and remote monitoring visits to assess compliance; Identify and initiate qualified investigative sites; Perform trial close-out and material retrieval; Track trial status and generate progress reports; Facilitate communication between sites, clients, and project teams; Respond to regulatory audits and inspections.
Seniority
Mid-level, hands-on IC