Clinical Research Associate II
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Job Description
Clinical Research Associate monitoring clinical studies for Precision for Medicine, a CRO integrating trial execution with scientific, laboratory, and data-science expertise. Coordinating site setup, regulatory submissions, initiation visits, compliance, and risk mitigation across Belgium and the Netherlands.
Responsibilities:
- Monitor and own the progress of clinical studies at investigative sites
- Ensure clinical studies are conducted, recorded, and reported according to protocol, SOPs, ICH-GCP, applicable regulations, and standards
- Coordinate activities required to set up and monitor studies
- Identify investigators
- Help prepare regulatory submissions
- Conduct pre-study and initiation visits
- Identify potential study risks and propose mitigation solutions
- Prepare for investigator meetings, site visits, and project team updates
- Handle conflict using resolution strategies
- Support monitoring visits in Belgium and occasionally sites in the Netherlands
Requirements:
- Life science degree and/or equivalent experience
- At least 2 years of experience as a CRA in a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies
- Site management or equivalent experience in clinical research
- Availability for domestic travel, including overnight stays
- Availability for approximately 50–60% travel commitment
- Excellent communication and organizational skills
- Team-player approach
- Evidence of a client-focused approach
- Fluency in English and Dutch
Benefits:
- Lower than average number of protocols, supporting protocol expertise
- Reasonable travel and improved work/life balance
- Support from direct line management
- Opportunity to have influence and impact in a smaller CRO
- High CRA retention and enjoyable quality of life
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