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 monitoring investigational sites, ensuring compliance with protocols, regulations and SOPs, and safeguarding subject safety and data integrity.

Key responsibilities

• Conduct remote and on‑site monitoring visits using a risk‑based approach.
• Apply root cause analysis and critical thinking to identify site process failures and implement corrective actions.
• Perform Source Data Review (SDR), Source Data Verification (SDV) and Case Report Form (CRF) review.
• Assess investigational product inventory and related documentation.
• Document observations in monitoring reports and letters, adhering to business writing standards.
• Escalate deficiencies promptly and follow issues through to resolution.
• Maintain regular communication with sites to ensure protocol adherence and timely data capture.
• Support investigator payment processes and provide trial status updates to the Clinical Team Manager.
• Update study systems (CTMS) and perform quality checks on generated reports.

Required profile

• Proven independent monitoring experience as a Clinical Research Associate.
• Fluency in Dutch, English and French.
• Ability to work remotely or from the Brussels office.
• Strong understanding of ICH‑GCP guidelines and applicable regulations.

Required skills

• Risk‑based monitoring
• Root cause analysis
• ICH‑GCP compliance
• Clinical Trial Management System (CTMS) usage
• Source Data Review (SDR) and Source Data Verification (SDV)
• Case Report Form (CRF) review
• Investigational product inventory management