CRA Germany

In this role, you will monitor clinical sites to ensure regulatory and protocol adherence, overseeing data integrity and patient safety. You will collaborate with cross-functional teams across Austria and Germany, applying GCP/ICh guidance and SOPs. You’ll manage site activities, data capture and IP-related tasks, while supporting recruitment and audit readiness. This position offers exposure to global clinical monitoring practices within a mission-driven environment that values collaboration and continuous development.

• career development and progression
• supportive line management
• technical and therapeutic area training
• peer recognition
• total rewards program
• Total Self culture

• Perform site qualification, initiation, interim monitoring, site management and close-out visits (on-site or remote)
• Assess site processes, conduct Source Data Review, ensure accurate CRF data and timely query resolution
• Manage IP inventory, labeling, dispensing in compliance with protocol and GCP/local regs
• Reconcile ISF with TMF and ensure archival of essential documents
• Prepare and maintain project documentation (letters, trip reports, logs) and support recruitment/awareness strategies
• Attend Investigator Meetings and sponsor meetings; provide site-level audit readiness guidance
• Track observations and action items in tracking systems; ensure training and compliance of site staff
• Understand project scope, budgets, timelines and adapt to changing priorities
• Coordinate with primary site personnel or Central Monitoring Associate as needed
• Ensure training on applicable requirements across sites and projects

• Bachelor’s degree or RN in a related field or equivalent
• Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
• Previous monitoring experience in Germany
• Good computer skills and willingness to adopt new technologies
• Fluency in German and English
• Excellent communication, presentation and interpersonal skills
• Ability to travel for monitoring visits in Austria

• excellent communication
• presentation skills
• interpersonal skills
• EDC systems and electronic data capture
• data review and query resolution
• IP inventory and handling