Clinical Research Associate (CRA) – Belgium

About the role

The Clinical Research Associate (CRA) will act as the primary liaison between investigational sites, Novotech, and the study sponsor. You will ensure participant safety, data integrity, and compliance with ICH GCP, local regulations, and company SOPs while supporting the successful execution of clinical trials across Belgium.

Key responsibilities

• Build and maintain strong relationships with principal investigators, study coordinators, pharmacists, and site staff.
• Prepare and submit essential site documents, supporting ethics and regulatory approvals.
• Drive participant recruitment to meet site targets and develop site‑specific recruitment plans.
• Conduct site monitoring visits (selection, initiation, routine monitoring, close‑out) both onsite and remotely, following the Clinical Monitoring Plan.
• Verify informed consent, eligibility, protocol adherence, drug accountability, and adverse event reporting.
• Ensure accurate and complete case report form (CRF) data, resolve queries, and maintain source document verification.

Required profile

• Graduate degree in clinical, life sciences, or a related field.
• 2–3 years of experience as a Clinical Research Associate in the pharmaceutical or clinical research industry.
• Strong time‑management, attention to detail, and ability to work collaboratively in a team.
• Computer literacy and proficiency with standard clinical trial software.

Required skills

• Knowledge of ICH GCP guidelines and local regulatory requirements.
• Experience with site monitoring, documentation, and regulatory submissions.
• Familiarity with clinical trial workflows, CRF completion, and adverse event reporting.