Senior Clinical Research Associate

Senior Clinical Research Associate
- Belgium About the Employer Chloe O'Shea has partnered with a small, specialist clinical CRO providing tailored clinical research services across Belgium and the Benelux region. The organization offers a collaborative, quality-focused environment where employees have the opportunity to take on meaningful responsibilities and contribute directly to the successful delivery of clinical trials. Role Overview As a Senior Clinical Research Associate, you will play a leading role in the set-up, execution, and oversight of Phase I–IV clinical trials across Belgium, with occasional travel throughout the Benelux region. Leveraging your monitoring experience, you will ensure studies are conducted in compliance with ICH-GCP, EU and local regulations, study protocols, and standard operating procedures. You will support clinical trial start-up activities, oversee site monitoring, provide regulatory guidance, and mentor junior team members. This role requires a proactive approach to quality, compliance, and risk management while building strong relationships with investigators, sponsors, and study sites

Key Responsibilities
- Ensure clinical studies are conducted and documented in compliance with ICH-GCP, EU and local regulations, study protocols, SOPs, and contractual requirements.
- Act as the primary liaison between Project Managers and investigator site staff.
- Support study start-up activities, including feasibility assessments, site selection, and submissions to Ethics Committees and Regulatory Authorities.
- Lead and support investigator sites throughout Phase I–IV clinical trials, clinical investigations, and performance studies.
- Conduct on-site and remote monitoring visits according to the Monitoring Plan.
- Verify the accuracy, completeness, and consistency of CRFs, source documentation, and trial records.
- Safeguard participant rights, safety, and well-being while ensuring protocol adherence and eligibility compliance.
- Review safety documentation and ensure timely reporting of adverse events and implementation of corrective actions where required.
- Identify protocol deviations, risks, and quality issues, recommending and following up on corrective and preventive actions (CAPAs).
- Prepare and maintain study documentation and monitoring reports.
- Monitor changes in applicable clinical research legislation and communicate regulatory updates internally.
- Report study progress, findings, and risks to Project or Line Managers, escalating issues when appropriate.
- Mentor, coach, and support junior Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs).
- Deliver assigned activities within agreed timelines and budgets. Candidate Profile
- Master's degree in Life Sciences or a related discipline.
- Minimum of 2 years' experience in clinical study start-up, coordination, and/or monitoring, including both on-site and remote monitoring.
- Strong knowledge of ICH-GCP, EU clinical research regulations, and applicable guidelines.
- Experience working within different SOP frameworks.
- Excellent written and verbal communication skills in Dutch, French, and English.
- Strong documentation, reporting, and presentation skills.
- Highly organized with excellent attention to detail and a strong commitment to quality and compliance.
- Able to work independently while collaborating effectively within multidisciplinary teams.
- Proficient in Microsoft Office applications, particularly Word and Excel.
- Flexible, solution-oriented, and confident in stakeholder communication.
- Willingness to travel to investigator sites across the Benelux region.
- Valid Category B driving licence. What's on Offer
- Competitive salary and benefits package.
- Flexible hybrid working with the opportunity to work from home alongside office collaboration.
- Modern offices located in the Flemish region.
- A varied role offering autonomy, responsibility, and exposure to diverse clinical research projects.
- Ongoing professional development with opportunities to progress into lead or mentoring roles.
- A supportive, close-knit team environment focused on collaboration, quality, and continuous improvement.
- Opportunity to make a meaningful impact on clinical trial quality and patient outcomes.
- Immediate start available. If you are a motivated professional looking to advance your career as a Clinical Research Associate, we would love to hear from you. Apply now and join a team dedicated to driving innovation in clinical trials