Senior Clinical Research Associate

AL Solutions; Vlaanderen; Hybride; EUR 70 000 - 95 000; Plein temps

Avantages offerts par ce poste

Flexible hybrid work

Modern Flemish region offices

Professional development

Mentoring opportunities

Résumé du poste

AL Solutions is seeking a Senior Clinical Research Associate to lead set-up, execution and oversight of Phase I–IV trials across Belgium with occasional travel in the Benelux region. You will monitor studies to ensure compliance with ICH-GCP, EU and local regulations, study protocols, and SOPs, while mentoring junior team members.

The role involves start-up activities, site monitoring (on-site and remote), regulatory guidance, and contributing to quality and risk management within a

Qualifications

• Master's degree in Life Sciences or related discipline.
• Minimum 2 years' experience in clinical study start-up, coordination, and/or monitoring including on-site and remote monitoring.
• Strong knowledge of ICH-GCP, EU clinical research regulations, and applicable guidelines.
• Experience with different SOP frameworks.

Responsabilités

• Ensure studies are conducted in compliance with ICH-GCP, EU and local regulations, protocols, SOPs and contracts.
• Serve as primary liaison between Project Managers and investigator site staff.
• Support study start-up activities including feasibility assessments, site selection and ethics/regulatory submissions.
• Lead and support investigator sites through Phase I–IV trials, investigations, and performance studies.
• Perform on-site and remote monitoring visits per Monitoring Plan.
• Verify accuracy and completeness of CRFs, source docs, and trial records.

Connaissances

Dutch language

French language

English language

Formation

Master's degree in Life Sciences

Outils

Microsoft Word

Microsoft Excel

Description du poste

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.

If you are a motivated professional looking to advance your career as a Clinical Research Associate, we would love to hear from you.