Clinical Research Associate (CRA)

Responsibilities

• Monitor clinical trials in the field of cell therapy (e.g., CAR-T, TCR-T, Treg) across all study phases
• Ensure correct, complete, and timely submission of study data and documentation
• Create high-quality monitoring reports and follow-up letters after site visits
• Utilize study systems such as WBDC, IVRS, and maintain the CTMS
• Participate in international study team meetings and investigator meetings
• Assist in the selection of trial sites and assessment of recruitment potential
• Initiate study sites, provide training, and support site personnel
• Monitor recruitment performance, site quality, and escalate deficiencies to study management
• Maintain proactive communication with study sites and local study teams

Requirements

• Degree in natural sciences, medicine, or a comparable field
• Proven experience as a monitor in clinical trials specifically involving cell therapy
• Excellent knowledge of ICH-GCP and relevant regulatory requirements (AMG)
• Proficiency in both German and English
• Strong analytical, organizational, and solution-oriented thinking skills
• Willingness to travel and stay overnight for site monitoring

Benefits

• Attractive pipeline and access to innovative products
• Individual development opportunities and a focus on lifelong learning
• Collaborative and passionate team environment with high levels of trust
• Flexible and agile working spaces in the heart of Hamburg
• A diverse, inclusive, and unbiased work environment
• Commitment to sustainability with a goal to be CO2-negative by 2030

About the Company

AstraZeneca is a leading global biopharmaceutical company that places science at the heart of everything it does. We work passionately every day to improve the lives of patients through the development of life-changing medicines and innovative therapies.