Clinical Research Associate II (m/f/d) – Belgium
- Jotec GmbH Jobportal
- Kaufmännische Berufe (Sonstige)
- Publiziert: 02.12.2025
Your Strength
- 18 months to 4 years of site monitoring experience in clinical research
- Ability to work independently with limited supervision
- Excellent understanding of GCP, ISO 14155, MDR, FDA, EU, and local clinical regulations
- Strong communication and relationship-building skills with investigators and site personnel
- Proficiency in documentation, reporting, and data review processes
- Fluent in Dutch and English; additional language skills are an asset
- Organized, proactive, and detail-oriented approach
- Familiarity with electronic data capture systems and remote monitoring tools
Your Contribution
- Manage 10–15 clinical study sites (class 2–3 devices) from start-up to close-out
- Conduct and independently manage site monitoring visits (on-site and remote)
- Act as main point of contact between sites, sponsors, and stakeholders
- Review and verify clinical data and source documents for accuracy and compliance
- Prepare site visit reports, follow-up on action items, and maintain study documentation
- Conduct site selection, initiation, and close-out visits
- Support execution of clinical study protocols and ensure adherence to regulatory requirements
- Participate in quality assurance activities, audits, CAPAs, and training sessions
- Mentor and guide junior CRAs and assist in coordination of project-related tasks
- Ensure accurate and timely data transmission and DCF resolution
- Collaborate cross-functionally with Clinical Affairs, RA/QA, R&D, and external vendors
Our Strength
- A mission-driven and international Clinical Affairs team
- Diverse and impactful projects in the cardiovascular device space
- A structured onboarding process and professional development support
- Hybrid work flexibility and attractive benefits including pension plan and EGYM Wellpass
- Collaborative culture and strong clinical partnerships across EMEA
Contact
JOTEC GmbH, a wholly owned subsidiary of Artivion, Inc.,
Lotzenäcker 23, 72379 Hechingen
www.artivion.com