Clinical Research Associate

Oxford Global Resources; Brussel Hoofdstad; Sur place; EUR 55 000 - 75 000; Plein temps

Résumé du poste

Oxford Global Resources seeks a Clinical Research Associate to monitor clinical investigations for medical devices at Brussels-area sites. The CRA will ensure patient safety, data integrity and protocol compliance, and act as the primary liaison with investigators and study staff.

The role requires up to 80% travel, onsite presence in Brussels at least once weekly, and fluency in English, Dutch and French. The candidate will oversee SDV, ISF/TMF readiness and audit support.

Qualifications

• Bachelor's or Master's degree in science or related field.
• Minimum 2 years of CRA experience.
• Hands-on monitoring across multiple sites.
• Strong understanding of standards and regulations (GCP/ISO 14155/MDR).
• Excellent communication and interpersonal skills.

Responsabilités

• Perform site qualification, initiation, monitoring, and close-out visits.
• Verify data accuracy and SDV.
• Identify protocol deviations and implement corrective actions.
• Train site staff on protocols and device handling.
• Monitor site performance, recruitment and retention.
• Prepare monitoring visit reports and follow-up letters.
• Escalate findings, safety issues, and risks to management.

Connaissances

EDC systems

CTMS platforms

Formation

Scientific Bachelor's or Master's degree

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.

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.