Senior Clinical Research Associate, Belgium
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Job Description
Senior Clinical Research Associate monitoring pharmaceutical and biotech clinical trials in Belgium. Ensuring site compliance, data quality, documentation, and audit readiness through remote and on-site visits.
Responsibilities:
- Perform and coordinate clinical monitoring and site management activities
- Conduct remote or on-site visits to assess protocol and regulatory compliance
- Manage required documentation, sponsor procedures and monitoring environments
- Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs
- Maintain audit readiness and collaborative relationships with investigational sites
- Monitor investigator sites using risk-based monitoring, including RCA, SDR, SDV and CRF review
- Assess investigational product inventory and records
- Document observations and escalate deficiencies through resolution
- Maintain contact with investigative sites between monitoring visits
- Track trial status and provide progress reports to the Clinical Team Manager
- Update and quality-check clinical trial management systems
- Participate in investigator meetings and identify potential investigators
- Initiate clinical trial sites and ensure trial closeout and retrieval of materials
- Ensure essential documents are complete and conduct on-site file reviews
- Support project publications, tools, trip report reviews, newsletters and CRA team calls
- Facilitate communication among sites, the client company and the project team
- Respond to company, client and regulatory requirements, audits and inspections
- Complete expense reports and timesheets
- Contribute to process-improvement initiatives
- Travel frequently to site locations, generally 60–80%, with possible overnight stays
Requirements:
- Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification
- Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
- 2+ years of clinical research monitor experience
- Previous independent monitoring CRA experience
- Valid full driver's licence
- Fluency/good language and grammar skills in Dutch, English and French
- Effective clinical monitoring skills
- Understanding of medical/therapeutic area knowledge and medical terminology
- Understanding and application of ICH GCPs, applicable regulations and procedural documents
- Critical thinking, root cause analysis and problem-solving skills
- Ability to manage Risk Based Monitoring concepts and processes
- Oral and written communication skills
- Interpersonal, organizational and time-management skills
- Microsoft Office proficiency and ability to learn appropriate software
- Presentation skills
- Ability to work independently or in a team
- Flexibility and adaptability
- Ability to comply with sponsor/client/site requirements
Benefits:
- Fully remote in Belgium or hybrid/office based from the Brussels site
- Full-time employment
- Standard Monday-Friday work schedule
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