Clinical Research Associate, Cell Therapy – Western Germany

This is a fully remote position, open to applicants in Germany.

📋 Description

• Overseeing clinical trials in cell therapy (e.g., CAR-T, TCR-T, Treg)

• Ensuring accurate, complete, and prompt transmission of study data and documents

• Actively participating in all phases of the study (feasibility, set-up, recruitment, maintenance, DBL [database lock], closure)

• Timely creation of high-quality monitoring visit reports and follow-up correspondence

• Utilizing relevant study systems such as WBDC and IVRS, along with maintaining the CTMS

• Engaging in international study team meetings and investigator meetings

• Assisting in site selection and evaluating recruitment potential

• Initiating study sites, providing training, support, and guidance to site staff

• Monitoring recruitment effectiveness, site performance, and quality, while escalating deficiencies to study management

• Maintaining proactive communication with study sites and the local study team

⛳️ Requirements

• A degree in a scientific or medical field or an equivalent qualification

• Demonstrated prior experience as a monitor in clinical trials related to cell therapy (e.g., CAR-T, TCR-T, Treg)

• Interest in contemporary monitoring methodologies such as Risk-Based Quality Management and remote monitoring

• Strong knowledge of ICH-GCP

• Familiarity with applicable laws (AMG) and regulatory standards

• Solid understanding of medical issues

• Comprehension of various study and process requirements, with the ability to establish the correct priorities

• Experience in monitoring electronic Case Report Forms (Web-Based Data Capture)

• Experience in preparing monitoring reports

• Proficiency in both German and English languages

• Structured and independent organizational skills along with analytical and solution-oriented thinking

• Strong teamwork capabilities and excellent communication skills

• Willingness to travel, including overnight stays

• Complete application package, including cover letter, CV, and relevant certificates

• Prior experience in cell therapy must be clearly and systematically detailed in the CV

🏝️ Benefits

• Opportunities for individual development and a commitment to lifelong learning

• A high-trust, appreciative environment that encourages idea contributions within a focused, passionate team

• Office location in the heart of Hamburg, facilitating collaborative, flexible, and agile working

• A diverse, inclusive, and non-discriminatory workplace

• A sustainable organization dedicated to becoming carbon-negative throughout the entire value chain by 2030