CRA II/Sr CRA - Sponsor-Dedicated FSP - Germany (m/f/d)
Core
Managing clinical trial sites across Germany to ensure compliance with protocols, ICH-GCP, and regulations while delivering high-quality, inspection-ready trials.
Role type
Senior Clinical Research Associate (Monitor)
Builds
Clinical trials for life-changing therapies
Domain
Clinical research / Life sciences
Deliverable
client delivery
Required skills
Risk-based monitoring (RBM), ICH-GCP compliance, site initiation and close-out, root cause analysis, CAPA principles, therapeutic area knowledge, medical terminology
Preferred skills
Process improvement, mentoring, cross-functional collaboration
Technologies
CTMS, Microsoft Office
Responsibilities
Perform on-site and remote monitoring visits, conduct source data verification (SDV) and CRF review, ensure investigational product accountability, document monitoring activities and follow-up letters, maintain audit and inspection readiness, provide trial status updates to the Clinical Team Manager, support study start-up and close-out activities
Seniority
Senior, hands-on IC
