Your Strength
- Minimum of 4 years of advanced experience in clinical research monitoring
- In-depth knowledge of regulations and guidelines related to clinical trials on human subjects (e.g., ISO 14155, GCP, MDR, EU, FDA)
- Ability to manage 10-15 study sites independently, from start-up to closure
- Excellent communication skills for site interaction, training, and issue resolution
- Strong collaboration and mentorship abilities -- CRA IIIs are expected to guide junior team members
- Hands-on experience with monitoring systems, data verification, and compliance tracking
- Strong organizational skills and the ability to manage multiple priorities
- Willingness to travel for site visits and meetings
- Fluency in German and English is required. Proficiency in the language of one of Germany's neighboring countries is an advantage, to support potential cross-border monitoring activities.
Your Contribution
- Independently manage all phases of site activities: identification, start-up, monitoring, and close-out
- Conduct monitoring visits in line with study plans and regulatory requirements
- Ensure compliance at investigational sites and act as the primary contact for site staff
- Build and maintain strong relationships with investigators and site personnel
- Identify risks, provide solutions, and ensure timely resolution of study-related issues
- Perform data review and verification for patient safety and protocol adherence
- Conduct site training, initiate visits, and support audit/inspection readiness
- Collaborate with other departments such as Data Management, Clinical Operations, and Medical Affairs
- Support investigator and coordinator meetings, and provide training or presentations as needed
- Mentor junior CRAs and contribute to continuous process improvement
- Participate in CAPA execution, audits, and ongoing quality assurance activities
Our Strength
- A purpose-driven Clinical Affairs team committed to quality and patient safety
- Onboarding and development in a structured, supportive environment
- Exposure to international clinical trials and cross-functional collaboration
- Flexible working conditions and career growth opportunities
- Attractive benefits including pension plan and EGYM Wellpass
Contact
JOTEC GmbH, a wholly owned subsidiary of Artivion, Inc.,
Lotzenäcker 23, 72379 Hechingen
www.artivion.com
