Clinical Research Associate II (m/f/d) – Belgium

JOTEC GmbH 2016; Remote; EUR 45.000 - 60.000; Vollzeit

Zusammenfassung

A leading medical device company is looking for a Clinical Research Associate II to manage and monitor clinical study sites in Belgium. This role involves site monitoring, regulatory compliance, and collaborating cross-functionally. Candidates should have 18 months to 4 years of experience in clinical research, excellent understanding of GCP and clinical regulations, and be fluent in Dutch and English. The company offers hybrid work flexibility and benefits including a pension plan and wellness programs.

Leistungen

Hybrid work flexibility

Pension plan

Wellness programs

Qualifikationen

• 18 months to 4 years of experience with site monitoring in clinical research.
• Excellent understanding of GCP, ISO 14155, MDR, FDA, EU regulations.
• Fluency in Dutch and English; additional languages advantageous.

Aufgaben

• Manage 10–15 clinical study sites from start-up to close-out.
• Conduct and manage site monitoring visits both on-site and remote.
• Collaborate with clinical and regulatory teams across functions.

Kenntnisse

Site monitoring experience in clinical research

Independent work with limited supervision

Understanding of GCP and clinical regulations

Strong communication and relationship-building skills

Fluent in Dutch and English

Organized and detail-oriented approach

Jobbeschreibung

It's a good feeling to know you're doing your best with purpose every day. At Artivion, we manufacture high-quality products and solutions for the treatment of aortic diseases. Together with surgeons worldwide, we save lives. In doing so, we rely on the strengths of each and every employee. Your strength counts, too: As an important link in the chain, you make a contribution to saving lives together with us. Contribute your strengths and let us grow together. We are hiring aClinical Research Associate II (m/f/d) – Belgium

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

Apply now and join the Artivion Team. We are looking forward to receiving your application documents in English directly via our online system.
Brian Russo,T: [phone]
JOTEC GmbH, a wholly owned subsidiary of Artivion, Inc.,
Lotzenäcker 23, 72379 Hechingen
www.artivion.com