Principle Clinical Research Associate

Sr/Principal Clinical Research Associate – Belgium (Home-Based / Hybrid, Cell & Gene Therapy)

Chloe O'Shea is partnering with a leading global CRO renowned for delivering innovative, high-quality solutions in clinical development. We are seeking a
Sr/Principal Clinical Research Associate
with
Cell and Gene Therapy experience
to join a dedicated FSP team in Belgium. This is an exciting opportunity to take ownership of site responsibilities, strengthen your expertise, and accelerate your career in clinical research, all while enjoying the flexibility of a home-based or hybrid position.

The Role

As a Sr/Principal CRA, you will manage clinical trial sites across Belgium for a dedicated FSP project. You will act as the primary point of contact for investigative sites, ensure compliance with study protocols, ICH-GCP, and local regulations, and oversee all aspects of site monitoring. This role is ideal for experienced CRAs with hands-on monitoring experience in advanced therapies who are ready to take on a senior-level responsibility within a supportive, specialized team.

Key Responsibilities

• Independently manage site qualification, initiation, monitoring, and close-out visits for Cell and Gene Therapy studies.
• Ensure strict adherence to ICH-GCP, local regulations, and sponsor SOPs.
• Conduct source data verification, investigational product accountability, and maintain accurate site documentation.
• Build and maintain strong professional relationships with site staff and study teams.
• Proactively identify, resolve, and escalate site-level challenges to keep studies on track.
• Maintain complete and accurate trial documentation in CTMS, eTMF, and EDC systems.

Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field.
• Proven CRA experience, ideally at Sr/Principal level, with hands-on monitoring in Cell and Gene Therapy.
• Knowledge of ICH-GCP and Belgian clinical trial regulations.
• Fluent in English and French; Dutch is a plus.
• Strong communication, organizational, and relationship-management skills.
• Based in Belgium, with flexibility for home-based or hybrid working.
• Available to start as soon as possible.

What's in It for You?

This role offers a
competitive salary and benefits package
, flexible working options, and the chance to take ownership of high-impact clinical trial sites in a cutting-edge therapeutic area. You will gain exposure to pioneering Cell and Gene Therapy studies, collaborate with an international team of experts, and further develop your career in clinical research at a senior level.

If you are a CRA with extensive hands-on experience in Cell and Gene Therapy looking to take on real responsibility and grow your career, we'd love to hear from you.
Apply today
to join a global team dedicated to advancing clinical research and making a tangible impact.