Senior Clinical Research Associate

This is a fully remote position, open to applicants in Belgium, +1 more country.

📋 Description

• Assume responsibility for investigative sites from the initiation phase through to study completion.

• Perform Site Qualification Visits, Site Initiation Visits, regular Monitoring Visits, Quality Oversight Visits, co-monitoring visits, and Close-Out Visits.

• Ensure adherence to study protocols, ICH-GCP guidelines, and relevant regulatory standards at the site.

• Confirm source documentation, informed consent processes, investigational product accountability, and essential regulatory paperwork.

• Identify, document, communicate, and escalate any protocol deviations, compliance issues, and risks associated with the study.

• Ensure that study milestones are met according to established timelines, including site activation, patient recruitment, database analysis, and study close-out.

• Develop and sustain relationships with investigators and site personnel.

• Ensure that site staff receive appropriate training and maintain qualifications throughout the duration of the study.

• Prepare monitoring reports, follow-up correspondence, and other study documentation.

• Collaborate with cross-functional teams, study management, and sponsor stakeholders.

• Assist in audit and inspection readiness activities.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related discipline.

• At least 3–5 years of independent clinical monitoring experience as a Clinical Research Associate (CRA).

• A minimum of 1 year of experience in Ophthalmology, with a focus on 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.

• Comprehensive knowledge of ICH-GCP, clinical trial regulations, and monitoring methodologies.

• Native or bilingual fluency in Dutch.

• Professional proficiency in English.

🏝️ Benefits

• Competitive compensation package.

• Comprehensive benefits.

• Opportunities for personal and professional development.

• A collaborative and innovative work environment.