CRA Freiburg region

In this CRA role, you will oversee clinical site activities to ensure study integrity and regulatory compliance. You’ll work with cross-functional teams to monitor data quality, patient safety, and protocol adherence across Germany, and support site qualification, initiation, monitoring, and close-out visits. The position offers exposure to risk-based monitoring, data review, and collaboration with global sponsors. You join a culture focused on development, Total Self, and making a meaningful impact from lab to life.

• career development
• peer recognition
• total rewards program
• supportive line management
• training and professional development
• Total Self culture

• Perform site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remote) ensuring ICH-GCP/GPP and protocol compliance
• Assess site performance and escalate issues with action plans
• Verify informed consent and protect subject confidentiality
• Conduct source data review and ensure accuracy/completeness of CRF data; drive query resolution
• Manage IP inventory, labeling, and compliance with storage/release protocol
• Reconcile ISF with TMF and ensure archiving of essential documents
• Support recruitment/retention strategies and track observations in tracking systems
• Coordinate training and communications with site teams; attend Investigator Meetings and sponsor meetings
• Prepare for audits and support audit readiness and follow-up actions
• Maintain knowledge of regulatory guidelines and complete required trainings
• Travel as required to monitor sites in Germany and Switzerland

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

• Excellent communication and interpersonal skills
• Adaptability to changing priorities
• Team collaboration and cross-functional coordination
• ICH-GCP knowledge
• GCP regulatory knowledge
• Source data verification and CRF data entry