Clinical Research Associate

For our client, a global medical device company, we are looking for a Clinical Research Associate.

Position Summary

The Clinical Research Associate (CRA) is responsible for monitoring and overseeing clinical investigations involving medical devices to ensure compliance with applicable regulations, Good Clinical Practice (GCP), study protocols, and company procedures. The CRA acts as the primary liaison between study sites and the sponsor, ensuring patient safety, data integrity, and successful study execution.

Key Responsibilities

• Perform site qualification, initiation, monitoring, and close-out visits.
• Ensure studies are conducted according to protocol, GCP, ISO 14155, MDR requirements, and applicable local regulations.
• Verify the accuracy, completeness, and consistency of clinical data through source data verification (SDV).
• Identify protocol deviations and ensure appropriate corrective actions are implemented.
• Build and maintain strong relationships with investigators, study coordinators, and site personnel.
• Train site staff on study protocols, device handling, and study procedures.
• Monitor site performance, patient recruitment, and retention activities.
• Ensure timely resolution of site queries and issues.
• Ensure investigator site files (ISF) and trial master files (TMF) are maintained and audit-ready.
• Verify informed consent processes are performed correctly.
• Ensure compliance with guidelines, regulations and company SOPs.
• Support preparation for audits and inspections by regulatory authorities.
• Review CRFs/eCRFs for accuracy and completeness.
• Raise, track, and resolve data queries.
• Prepare monitoring visit reports and follow-up letters.
• Escalate significant findings, safety issues, and risks to project management.

Requirements

• Scientific Bachelor's or Master's degree.
• Minimum 2 years of CRA experience.
• Hands-on monitoring experience across multiple sites.
• Strong understanding of applicable standards and regulations.
• Familiarity with EDC systems and CTMS platforms.
• Ability to travel up to 80% of time.
• Excellent communication and interpersonal skills.
• Strong organisational and project management abilities.
• Ability to work independently and manage multiple studies simultaneously.
• Strong attention to detail and problem-solving skills.
• Proactive and quality-driven mindset.
• Fluency in English - Dutch - French.

Contract Information

• Onsite in Brussels at least once a week.
• Full-time.
• Ability to travel up to 80% of time.