Clinical Research Associate (m/w/d) - Zelltherapie - Region Norddeutschland in Hamburg, Deutschland

AstraZeneca seeks a Clinical Research Associate to monitor cell therapy trials across northern Germany. The role involves overseeing study data integrity, site coordination, recruitment performance, and regulatory compliance across all trial phases.

Responsibilities

• Monitor cell therapy clinical studies and ensure accurate, complete, timely data and document submission across all trial phases
• Generate high-quality monitoring reports and follow-up letters from site visits
• Operate study systems (WBDC, IVRS) and maintain CTMS database
• Initiate study sites, conduct staff training, and provide ongoing site support and guidance
• Track recruitment performance, site quality metrics, and escalate deficiencies to study leadership

Requirements

• Completed degree in natural sciences or medicine
• Demonstrated experience monitoring cell therapy clinical trials (CAR-T, TCR-T, Treg)
• Excellent ICH-GCP knowledge and understanding of relevant regulations (AMG)
• Proficiency with electronic Case Report Forms and monitoring reporting systems
• Fluent German and English language skills
• Strong analytical, organizational, and communication abilities
• Willingness to travel with overnight stays