Clinical Research Associate

Oxford Global Resources; Brussel; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

Oxford Global Resources in Brussels is seeking a Clinical Research Associate to monitor clinical investigations of medical devices ensuring GCP, ISO 14155, MDR compliance and data integrity.

The CRA will perform site qualification, initiation, monitoring, and close-out visits, manage queries, review CRFs, and support audits, with up to 80% travel and onsite presence in Brussels at least once a week.

Qualifications

• Scientific Bachelor's or Master's degree.
• Minimum 2 years of CRA experience.
• Travel up to 80% of time.
• Fluency in English, Dutch, and French.
• Experience monitoring across multiple sites.

Responsabilités

• Perform site qualification, initiation, monitoring, and close-out visits.
• Ensure studies are conducted according to protocol, GCP, ISO 14155, MDR, and local regulations.
• Verify data accuracy via SDV and manage data queries.
• Maintain ISF and TMF, audit-ready files and prepare monitoring visit reports.
• Escalate significant findings and coordinate with project management.

Connaissances

Strong communication

Organizational skills

Independent work

CRA monitoring

Formation

Bachelor's or Master's in Science

Outils

EDC systems

CTMS platforms

Description du poste

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.

• 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.