Senior Clinical Research Associate – Belgium (Remote/Hybrid)

About the role

We are looking for an experienced Senior Clinical Research Associate to join our Belgium team. The role can be performed fully remotely from anywhere in Belgium or on a hybrid basis from our Brussels office. You will be responsible for ensuring that clinical trials are conducted in compliance with protocols, regulations and good clinical practice.

Key responsibilities

• Perform risk‑based site monitoring visits, both on‑site and remote, to assess protocol adherence and regulatory compliance.
• Apply root cause analysis and corrective actions to resolve site process failures.
• Conduct source data verification (SDR), source data review (SDV) and case report form (CRF) review as required.
• Verify investigational product inventory and documentation.
• Document findings in monitoring reports and letters, escalating issues to the Clinical Team Manager.
• Maintain regular communication with sites to ensure timely resolution of findings.
• Update study systems such as the Clinical Trial Management System (CTMS) and provide status reports.
• Participate in investigator payment processes and support audit readiness.

Required profile

• Minimum several years of independent monitoring experience as a CRA.
• Fluency in Dutch, English and French.
• Strong analytical and problem‑solving abilities.
• Excellent written communication skills for report generation.

Required skills

• ICH‑GCP knowledge.
• Root Cause Analysis methodology.
• Proficiency with Clinical Trial Management Systems (CTMS).