Senior Clinical Research Associate

• Take ownership of investigative sites from site activation through study close-out
• Conduct Site Qualification Visits, Site Initiation Visits, routine Monitoring Visits, Quality Oversight Visits, co-monitoring visits, and Close-Out Visits
• Ensure site compliance with study protocols, ICH-GCP guidelines, and applicable regulatory requirements
• Verify source documentation, informed consent processes, investigational product accountability, and essential regulatory documentation
• Identify, document, communicate, and escalate protocol deviations, compliance concerns, and study risks
• Ensure study milestones are achieved according to timelines, including site activation, patient recruitment, database analyses, and study close-out
• Build and maintain relationships with investigators and site personnel
• Ensure site staff are appropriately trained and qualified throughout the study
• Prepare monitoring reports, follow-up letters, and study documentation
• Collaborate with cross-functional teams, study management, and sponsor stakeholders
• Support audit and inspection readiness activities

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field
• Minimum 3–5 years of independent clinical monitoring experience as a CRA
• Minimum 1 year of experience in Ophthalmology, especially retinal diseases such as Age-Related Macular Degeneration (AMD), Geographic Atrophy (GA), Diabetic Retinopathy, Diabetic Macular Edema, and Inherited Retinal Disorders
• Experience with Gene Therapy or Advanced Therapy programs
• Strong knowledge of ICH-GCP, clinical trial regulations, and monitoring practices
• Fluency in Dutch at native or bilingual level
• Professional proficiency in English

• Competitive compensation package
• Comprehensive benefits
• Opportunity for personal and professional growth
• Collaborative and innovative work environment