CRA II/Sr CRA - Sponsor-Dedicated FSP - Germany (m/f/d)
Core
Manage clinical trial sites across Germany ensuring compliance with protocol, ICH-GCP, and regulations using a risk-based monitoring approach.
Role type
Senior Clinical Research Associate (CRA)
Builds
High-quality, inspection-ready clinical trials for life-changing therapies
Domain
Clinical research / Life sciences
Required skills
Clinical monitoring, Risk-based monitoring (RBM), ICH-GCP compliance, Protocol adherence, Investigational product accountability, Root cause analysis, CAPA principles, Site initiation, Study close-out, Microsoft Office
Preferred skills
Therapeutic area knowledge, Medical terminology, Clinical systems proficiency (e.g., CTMS), Process improvement
Technologies
CTMS, Microsoft Office
Responsibilities
Perform on-site and remote monitoring visits, Conduct SDR, SDV, and CRF review, Identify and resolve site issues, Maintain audit and inspection readiness, Support study start-up and close-out activities, Provide trial status updates to Clinical Team Manager
Seniority
Senior, hands-on IC