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 quality, document completeness, and timely submission across all study phases.
Role type
Senior Clinical Research Associate (CRA)
Builds
Innovative cell therapy treatments for patients
Domain
Biopharmaceuticals / Cell Therapy
Deliverable
client delivery
Required skills
Clinical trial monitoring, Risk Based Quality Management, Remote Monitoring, ICH-GCP compliance, German pharmaceutical law (AMG), medical understanding, electronic data capture (eCRF), monitoring reporting, site selection, site initiation, training, recruitment performance monitoring, escalation management, proactive communication
Preferred skills
Experience with modern monitoring methodologies, structured independent organization, analytical thinking, solution-oriented mindset
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; Use study systems (WBDC, IVRS) and maintain CTMS; Participate in international study team and investigator meetings; Assist in site selection and recruitment potential assessment; Initiate study sites, train, and support site personnel; Monitor recruitment performance, site performance, and quality; Escalate deficiencies to study leadership; Communicate proactively with study sites and local teams