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

AstraZeneca seeks a Clinical Research Associate to monitor cell therapy trials in Hamburg, Germany. The role involves overseeing study data integrity, site management, recruitment tracking, 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
• Manage study systems including WBDC and IVRS; maintain central trial management system
• Initiate study sites, train site personnel, and provide ongoing support and guidance
• Track recruitment performance, site performance, and data quality; escalate deficiencies to study leadership

Requirements

• Completed degree in natural sciences or medicine or equivalent qualification
• Demonstrated monitoring experience in cell therapy clinical trials (CAR-T, TCR-T, Treg)
• Strong ICH-GCP knowledge and understanding of German pharmaceutical law (AMG)
• Experience with electronic case report forms and web-based data capture systems
• Fluent German and English language skills
• Interest in modern monitoring approaches such as risk-based quality management and remote monitoring
• Structured, independent work style with analytical and solution-oriented thinking