CRA South-West Germany

As a CRA for a single sponsor partnership in Germany, you will oversee site qualification, initiation, monitoring, and close-out visits to ensure regulatory and protocol compliance. You will work with cross-functional teams to assess site performance, protect patient safety, and support data integrity through remote and on-site activities. You will contribute to audit readiness and site training, helping to deliver high-quality clinical trials. This role offers impact in advancing regulatory-compliant trials within a global organization dedicated to bringing therapies to patients faster.

• Perform site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remote) with regulatory, ICH-GCP and GPP compliance
• Evaluate site performance and provide actionable recommendations; escalate issues to project team and implement action plans
• Maintain knowledge of ICH/GCP guidelines, regulations, and SOPs/processes
• Verify informed consent procedures and protect subject confidentiality
• Conduct Source Document Review and ensure accurate CRF data; drive query resolution to closure
• Manage IP inventory, reconciliation, and ensure proper IP labeling, import, release/return
• Reconcile ISF with TMF and ensure archiving of essential documents
• Document activities via required project documents and support recruitment and retention strategies
• Understand project scope, budgets, timelines; manage site-level communication to meet objectives
• Prepare for and attend Investigator Meetings and sponsor meetings; participate in global monitoring and training sessions
• Provide guidance towards audit readiness and support follow-up actions
• Maintain training and knowledge of regulatory requirements and SOPs
• Ensure site staff training and compliance with requirements
• Prepare for audits and follow-up actions

• Bachelor’s degree or RN in related field or equivalent
• Knowledge of GCP/ICH guidelines and regulatory requirements
• Previous monitoring experience in Germany
• Good computer skills and adaptability to new technologies
• Fluency in German and English
• Excellent communication, presentation and interpersonal skills
• Ability to travel for monitoring visits within Germany

• Excellent communication
• Interpersonal skills
• Adaptability to changing priorities
• GCP/ICH knowledge
• IP inventory and handling
• Source data review and CRF data verification