Senior Regional Clinical Research Associate

Regional CRA (Oncology, Phase I) – FSP | Permanent | Remote (Belgium)

Location: Remote (Belgium-based)

Travel: 70–80%

Work Model: Fully remote (WFH)

Please Read Before Applying – Essential Requirements

To be considered for this role, you must meet all three of the following criteria:

• Fluency in Dutch and French
• Phase I clinical trial experience
• Oncology monitoring experience

If you do not meet all of the above, this role is unlikely to be a fit. We encourage you to explore other opportunities that may better align with your background.

About the Role

This is a permanent FSP (Functional Service Provider) position, embedded within a global clinical program. You will operate as a Regional CRA, taking ownership of site monitoring activities across Belgium within complex oncology studies.

You’ll play a key role in ensuring clinical trials are delivered to the highest standards of GCP, protocol compliance, and regulatory requirements, while working closely with investigators, study teams, and vendors.

Key Responsibilities

• Perform site selection, initiation, routine monitoring, and close-out visits
• Act as the primary contact for sites, investigators, and study coordinators
• Support feasibility and site selection activities
• Ensure trials are conducted in line with GCP, ICH guidelines, and SOPs
• Review and track AEs/SAEs, ensuring appropriate documentation and follow-up
• Contribute to clinical documentation (protocols, ICFs, monitoring plans, etc.)
• Support patient recruitment strategies and site engagement
• Assist with data review, validation, and query resolution
• Coordinate study supplies and tracking tools
• Participate in investigator meetings and CRA training activities
• Provide guidance and mentorship to junior CRAs, where needed

Your Background

• Degree in Life Sciences or equivalent (e.g. Nursing qualification)
• 5+ years CRA experience across full trial lifecycle (start-up to DBL)
• Strong experience in oncology trials (solid and/or haematological)
• Proven experience in early phase (Phase I) studies
• Solid understanding of:
• ICH-GCP and regulatory frameworks
• Clinical trial systems (e.g. EDC, CTMS, IVRS)
• Able to manage multiple sites and protocols effectively
• Comfortable working in a matrix, fast-paced environment
• Willing and able to travel extensively (70–80%)

Additional Information

• Regional focus: Belgium
• Site load: ~8–10 sites across 4–5 protocols
• Fully remote role with high field engagement