Clinical Research Associate (CRA) (m/w/d) – Zelltherapie (Außendienst)
Core
Monitoring clinical trials in the cell therapy area (e.g., CAR-T, TCR-T, Treg) to ensure data accuracy, document completeness, and timely submission across all study phases.
Role type
Field Clinical Research Associate (Cell Therapy)
Builds
Innovative cell therapy treatments for patients
Domain
Biopharmaceuticals / Cell Therapy
Deliverable
client delivery
Required skills
ICH-GCP knowledge, monitoring electronic Case Report Forms (eCRF), creating monitoring reports, site selection and recruitment potential assessment, training and coaching site staff, escalation of deficiencies, proactive communication with study centers and teams, structured self-organization, analytical and solution-oriented thinking
Preferred skills
Risk Based Quality Management (RBQM), Remote Monitoring, understanding of medical questions, setting priorities based on study requirements
Technologies
WBDC, IVRS, CTMS
Responsibilities
Monitor clinical studies in cell therapy, create high-quality monitoring reports and follow-up briefs, participate in international study team meetings and investigator meetings, initiate study centers, monitor recruitment performance and center quality, escalate issues to study leadership, communicate proactively with study centers and local teams
Seniority
Mid-level, hands-on field role
