Clinical Research Associate Belgium - Single Sponsor

Clinical Research Associate Belgium - Single Sponsor

Updated: January 7, 2026
Location: BEL-Remote
Job :

Clinical Research Associate (CRA) responsible for site qualification, site initiation, interim monitoring, site management activities and close‑out visits (performed on‑site or remotely) for clinical studies conducted in Belgium. The CRA ensures regulatory, ICH‑GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance at all sites.

• Performs site qualification, site initiation, interim monitoring, site management activities and close‑out visits; evaluates overall performance of sites and site staff, and recommends actions.
• Verifies appropriate informed consent procedures, protects confidentiality, and assesses safety and data integrity risks.
• Assesses site processes per the Clinical Monitoring/ Site Management Plan; conducts source document reviews; verifies clinical data in the case report form (CRF); resolves queries; and verifies compliance with electronic data capture.
• Performs investigational product (IP) inventory and reconciliation, verifies dispensing and administration as per protocol, and manages IP labeling and storage.
• Reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness; reconciles ISF with the Trial Master File (TMF). Ensures proper archiving of essential documents in accordance with local regulations.
• Documents activities via letters, trip reports, communication logs and other project documents as per SOPs; supports subject recruitment, retention and awareness strategies; and enters data into tracking systems to monitor observations and action items.
• Manages site‑level activities, budgets, timelines and communications to achieve project objectives; adapts quickly to changing priorities.
• Acts as primary liaison with site personnel (or collaborates with the Central Monitoring Associate) and ensures training and compliance with applicable requirements.
• Prepares for and attends Investigator Meetings, sponsor face‑to‑face meetings and global clinical monitoring/project staff meetings; attends required clinical training sessions.
• Provides guidance toward audit readiness and supports audit preparation and follow‑up actions.
• Maintains a working knowledge of ICH/GCP Guidelines, applicable regulations, and company SOPs; completes required training.

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Previous monitoring experience in Belgium.
• Good computer skills and adaptability to new technologies.
• Fluency in French and Dutch for monitoring purposes.
• Excellent communication, presentation and interpersonal skills.
• Ability to manage required travel.

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you require reasonable accommodation due to a disability, please contact .