CRA Bavaria

As a CRA in Germany, you ensure clinical trial integrity by monitoring sites and data, both on-site and remotely. You will manage site qualifications, initiation, interim monitoring, and close-out activities within regulatory and protocol guidelines. You support data quality, medication handling, and patient safety, collaborating with cross-functional teams to keep trials on track. This role offers scope to influence trial outcomes and audit readiness while working within a global sponsor environment.

• 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 and conduct Source Document Review; verify CRF data accuracy and completeness
• Manage IP inventory, reconciliation, and release according to protocol
• Ensure compliance with ICH-GCP and local regulations; apply CMP/SMP requirements
• Handle data capture, query resolution, and ISF/TMF reconciliation
• Train site staff and ensure adherence to SOPs; support recruitment and retention strategies
• Prepare for Investigator Meetings and sponsor-facing sessions; participate in global team meetings
• Support audit readiness and post-audit follow-up actions
• Maintain up-to-date knowledge of GCP guidelines and SOPs
• Travel for monitoring visits within Germany and Switzerland

• Bachelor’s degree or RN in related field
• 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 as required for monitoring visits

• strong communication
• interpersonal skills
• presentation能力
• GCP/ICH knowledge
• electronic data capture (EDC) awareness
• IP inventory and handling