Overview
We are currently partnering with a growing clinical research organization to recruit an experienced Senior Clinical Research Associate (Senior CRA) to join their clinical operations team based on-site in Antwerp.
In this role, you will take responsibility for the oversight and monitoring of clinical trials across multiple sites, ensuring studies are conducted in compliance with ICH-GCP guidelines, study protocols, and applicable regulatory requirements. You will also play a key role in supporting site performance, maintaining strong investigator relationships, and mentoring junior CRAs where needed.
This position offers the opportunity to work within a collaborative clinical development environment while contributing to the successful delivery of high-quality clinical research programs.
Key Responsibilities
• Perform all aspects of clinical trial monitoring including site selection visits (SSV), site initiation visits (SIV), site monitoring visits (SMV), and site close-out visits (SCOV)
• Ensure clinical trials are conducted in accordance with ICH-GCP, study protocols, SOPs, and regulatory requirements
• Act as the primary point of contact between the sponsor, CRO teams, and investigative sites
• Perform source data verification (SDV) to ensure data accuracy, completeness, and compliance
• Monitor patient safety and ensure appropriate reporting of adverse events, SAEs, and protocol deviations
• Maintain investigator site files and ensure all essential documents are accurate and audit-ready
• Support site feasibility assessments and investigator selection
• Provide guidance and mentoring to junior CRAs and site staff when required
• Contribute to study start-up, regulatory documentation, and ethics submissions where applicable
• Prepare detailed monitoring reports and follow-up letters within required timelines
• Participate in audit and inspection preparation activities
Requirements
• Bachelor's or Master's degree in Life Sciences, Biomedical Sciences, Nursing, Pharmacy, or related field
• 4–7+ years of experience as a Clinical Research Associate within a CRO, pharmaceutical, or biotechnology company
• Strong experience conducting full-cycle monitoring visits (SIV, SMV, SCOV)
• In-depth knowledge of ICH-GCP and clinical trial regulations
• Experience working with clinical trial management systems (CTMS) and electronic data capture (EDC) systems
• Strong communication and stakeholder management skills
• Ability to work independently while collaborating within cross-functional study teams
• Fluent English required; Dutch or French strongly preferred
• Ability to travel to clinical sites when required
Preferred Experience
• Experience monitoring Phase II–III clinical trials
• Exposure to oncology, cardiovascular, or medical device studies
• Previous mentoring or leadership responsibilities within a CRA team
What Our Client Offers
• Opportunity to work in a scientifically driven clinical research environment
• Competitive salary and benefits package
• Career development opportunities within clinical operations
• Exposure to international clinical trials and multidisciplinary study teams