Clinical Research Associate (m/w/d) – Zelltherapie - Region Norddeutschland
Core
Monitoring clinical trials in cell therapy (e.g., CAR-T, TCR-T, Treg) to ensure data quality, document submission, and site performance 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
ICH-GCP knowledge, cell therapy trial monitoring, risk-based quality management, electronic case report forms (eCRF), site selection and initiation, regulatory compliance (AMG), medical understanding, data analysis, project prioritization
Preferred skills
Remote monitoring experience, advanced study system proficiency (WBDC, IVRS, CTMS), leadership in site training
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 study center selection and recruitment potential assessment; Initiate study centers and train site personnel; Monitor recruitment performance and site quality, escalating issues to study leadership; Proactively communicate with study centers and local teams.
Seniority
Senior, hands-on IC