Clinical Research Associate (CRA) (m/w/d) – Zelltherapie
Core
Monitoring clinical trials in cell therapy (e.g., CAR-T, TCR-T, Treg) to ensure data integrity, document submission, and patient safety across all study phases.
Role type
Senior Clinical Research Associate (Cell Therapy)
Builds
Innovative cell therapy treatments for patients
Domain
Biopharmaceuticals / Cell Therapy
Required skills
Clinical trial monitoring, Risk Based Quality Management, ICH-GCP compliance, German and English language proficiency, site selection and initiation, data management systems (WBDC, IVRS, CTMS), recruitment performance monitoring, regulatory knowledge (AMG), medical understanding
Preferred skills
Remote monitoring experience, structured organization, analytical thinking, team collaboration
Technologies
WBDC, IVRS, CTMS
Responsibilities
Monitor clinical trials in cell therapy ensuring correct and timely data/document submission, create high-quality monitoring reports and follow-up briefs, participate in international study team meetings and investigator meetings, assist in site selection and recruitment potential assessment, initiate study sites and train site personnel, monitor recruitment performance and site quality, escalate issues to study leadership, communicate proactively with study sites and local teams