Job Summary
As a Clinical Research Associate (CRA), you will play a pivotal role in the execution and oversight of clinical trials. Acting as the bridge between the study sponsor and clinical sites, you will ensure the ethical and efficient conduct of studies, safeguard patient safety, and uphold data integrity and regulatory compliance. From study start-up to close-out, your contributions will be vital to the success of our clinical programs. This Position reports to the Clinical Program Manager IO, Florence Chow.
Job Responsibilities
1. Study Preparation & Conduct: Support documentation, contribute to protocol and plan development, manage CTMS entries, and assist in audit readiness.
2. Site Management & Monitoring: Conduct feasibility, initiation, follow-up, and close-out visits; ensure protocol adherence and subject safety.
3. Regulatory Compliance: Ensure compliance with MDR, ISO-14155, GDPR, GCP, and local regulations; assist with submissions to Ethics Committees and Authorities.
4. Data Integrity & Safety Monitoring: Perform source data verification, track discrepancies, and monitor adverse events.
5. Communication & Collaboration: Liaise with sponsors, sites, and regulatory bodies; foster strong site relationships and collaborate with cross-functional teams.
6. Documentation & Reporting: Maintain essential documents in eTMF, prepare visit reports, and contribute to clinical investigation reports.
7. General: Adhere to SOPs, represent the company professionally, and provide periodic updates to management.
Profile Description
8. Master’s degree in Life Sciences or equivalent experience in a CRA role.
9. Proven experience in clinical trials; medical device experience is a strong plus.
10. You have worked on studies in Oncology, Cardiology, or Peripheral Vascular Disease.
11. Strong integrity, attention to detail, and understanding of data protection regulations
12. Comfortable working in an international environment, able to navigate the complexity of a multinational organisation.
13. Fluent in English; knowledge of an additional European language is preferred
14. Self-directed with the ability to work independently, combined with good communication skills to keep your internal stakeholders updated.
15. Willingness to travel up to 50%
16. Located in Belgium, able to come to the office in Leuven at least 2 days per week.
Offer
17. A meaningful role in a mission-driven organization focused on patient outcomes
18. The opportunity to work on impactful clinical studies in a global setting
19. A collaborative and supportive team environment
20. Professional growth and development opportunities
21. Flexibility and autonomy in your work