Clinical Research Associate (CRA) (m/w/d) – Zelltherapie (Außendienst)
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
Deliverable
client delivery
Required skills
Clinical trial monitoring, Risk Based Quality Management, Remote Monitoring, ICH-GCP compliance, German law (AMG) knowledge, medical question understanding, electronic CRF monitoring, monitoring report creation
Preferred skills
Feasibility study planning, center selection, recruitment potential assessment, site initiation, staff training, performance monitoring, escalation management
Technologies
WBDC, IVRS, CTMS
Responsibilities
Monitor clinical trials in cell therapy including data and 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/support site personnel; Monitor recruitment performance and site quality; Escalate deficiencies to study leadership; Communicate proactively with study sites and local teams
Seniority
Senior, hands-on IC