CRA – Future Roles (Germany)

As a Clinical Research Associate, you will oversee site qualification, initiation, monitoring, and close-out activities to ensure regulatory and protocol compliance. You’ll work with cross-functional teams to protect patient safety and data integrity across trials, including real-world late-phase studies. The role blends on-site and remote monitoring, data review, and collaboration with investigators to drive study success. This opportunity offers growth within a global organization that values development and diverse perspectives.

• Total Self culture
• career development and progression
• peer recognition
• total rewards program

• Conduct site qualification, initiation, monitoring, and close-out visits (on-site or remote) ensuring GCP/ICH compliance
• Evaluate site performance and staff, escalating issues and proposing corrective actions
• Ensure informed consent processes and patient confidentiality are maintained
• Perform CMP/SMP tasks: source data review, CRF data verification, and query resolution
• Manage IP inventory, labeling, and dispensing per protocol; ensure compliance with IP handling
• Review ISF and TMF for accuracy and archiving requirements
• Support patient recruitment and retention; track observations and actions in tracking systems
• Collaborate with sponsors and sites to ensure timelines, budgets, and deliverables are met
• Prepare for Investigator Meetings and sponsor meetings; participate in training and audits
• Assist in audit readiness and follow-up actions; adapt to project changes and priorities
• Provide site-level training and ensure compliance with local requirements for studies
• Contribute to real-world late-phase study design and data collection
• Liaise with sponsor affiliates, medical science liaisons, and local country staff

• Bachelor’s degree in related field or RN; equivalent combinations considered
• Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
• Strong computer skills and ability to adopt new technologies
• Excellent communication, presentation, and interpersonal skills
• Willingness to travel up to 75%
• Experience with data capture, source data verification, and ISF/TMF processes (preferred)

• Excellent communication and interpersonal skills
• Adaptability to changing priorities
• Collaborative mindset and team orientation
• Knowledge of GCP/ICH guidelines
• Experience with electronic data capture and CRF data entry
• Source Document Review and query resolution