CRA II Germany - multisponsor

As a CRA II for our multisponsor team in Germany, you oversee site performance and trial data integrity through monitoring and site management. You align with ICH-GCP, GPP and protocol requirements, liaising with site staff and project teams to resolve issues and keep study timelines on track. You cover remote and on-site activities, including IP handling, ISF/TMF reconciliation, and data verification, while contributing to audit readiness. This role supports patient safety and trial quality in a fast-paced, collaborative environment.

• Perform site qualification, initiation, interim monitoring, and close-out visits (on-site or remote)
• Assess site performance and escalate issues with action plans
• Maintain knowledge of ICH/GCP and applicable regulations; follow SOPs
• Verify informed consent and protect patient confidentiality
• Conduct Source Document Review and ensure accurate CRF data entry
• Resolve data queries and drive timely closure
• Manage IP inventory, labeling, and adherence to protocol for dispensing
• Reconcile ISF and TMF, ensure archiving per guidelines
• Support recruitment/retention strategies and track observations in systems
• Prepare for/attend Investigator Meetings and sponsor meetings; participate in training
• Assist in audit readiness activities and post-audit follow-up
• Communicate with sites to ensure training and compliance
• Travel up to 75% as required and adapt to changing priorities
• Maintain tracking and reporting using available systems

• Bachelor’s degree or RN in a related field or equivalent
• Knowledge of GCP/ICH and relevant regulatory requirements
• Two years of monitoring experience
• Strong computer skills and adaptability to new technologies
• Excellent communication and interpersonal skills
• Fluency in German and English
• Location northeast Germany; travel within DACH region possible
• Ability to manage travel up to 75%

• communication
• interpersonal skills
• problem-solving
• ICH-GCP
• Source Data Review
• electronic data capture (EDC)