CRA I (m/f/d) - FSP Germany
Core
Manage clinical trial sites across Germany to ensure studies are conducted in compliance with protocol, ICH-GCP, and regulations.
Role type
Clinical Research Associate (Monitor)
Builds
Clinical trials for life-changing therapies
Domain
Clinical research / Life sciences
Deliverable
client delivery
Required skills
Clinical monitoring, Risk-based monitoring (RBM), ICH-GCP compliance, Protocol adherence, Investigational product accountability, Root cause analysis, CAPA principles, Medical terminology
Preferred skills
Therapeutic area knowledge, Clinical systems proficiency (CTMS), Process improvement
Technologies
CTMS, Microsoft Office
Responsibilities
Perform on-site and remote monitoring visits, Conduct source data verification (SDV) and CRF review, Identify and resolve issues using root cause analysis, Maintain audit and inspection readiness, Support study start-up and close-out activities, Provide trial status updates to Clinical Team Managers
Seniority
Junior to Mid-level, hands-on IC
