Clinical Research Associate (CRA) - Cell Therapy (Field Service) (m/f/d)

We are looking for a fixed job Clinical Research Associate (CRA) (m/w/d) Influence: Monitoring of clinical studies in the field of cell therapy (e.g. CAR-T, TCR-T, Treg) including ensuring the correct, complete and timely transmission of study data and documents as well as active participation in all phases of study (Feasibility, Set-up, Recruitment, Maintenance, DBL, Closure) Timely creation of high-quality reports and follow up letters of monitoring visits Safe application of relevant study systems, e.g. WBDC, IVRS, ... and maintenance of CTMS Participation in international study team meetings and test medical meetings Participation in the selection of test centres and assessment of recruitment potential Initiation of study centres, training, support and guidance of the centre staff Constant monitoring of recruitment performance, centre performance and quality, escalation of shortcomings to the study management Proactive communication to the study centre and the local study team

Strengths prove: Completed scientific/medical studies or comparable Detectional experience as a monitor:in clinical trials with cell therapy (e.g. CAR-T, TCR-T, Treg) Interest in modern monitoring methods such as Risk Based Quality Management and Remote Monitoring Excellent ICH-GCP knowledge for the proper conduct of clinical trials Knowledge of relevant laws (AMG) and regulatory requirements Good understanding of medical issues Understanding different study and process requirements and setting the right priorities derived therefrom Experience in the Monitoring of Electronic Case Report Forms (Web Based Data Capture) and in the Creation of Monitoring Reports Very good knowledge of German and English Structured, independent organization and analytical and solution-oriented thinking High team capability as well as ability and strong communication skills Ready to travel incl. Overnight stay

It offers: an attractive pipeline and innovative products individual development opportunities and the focus on lifelong learning lots of trust, appreciation and space for co-design in a focused and passionate team Office space in the heart of Hamburg, which enables collaborative, flexible and agile cooperation a diverse, inclusive and prejudice-free working environment, committed to the Charter of Diversity, not only allows differences, but actively promotes and welcomes and takes into account applications from all qualified applicants, regardless of their characteristics a sustainable company that becomes CO2 negative by 2030 along the entire value chain Please submit a full application consisting of letters, CV and relevant certificates. In the CV, the experience in cell therapy should be clearly and structured. .