Overview
In this role you will monitor clinical studies at investigative sites to ensure trial activities align with protocol, SOPs, and ICH-GCP. Based in Belgium or the Netherlands with remote work and regular site travel, you will support oncology trials and contribute to high-quality data and outcomes. You will coordinate study setup and monitoring activities, from investigator identification to regulatory submissions and initiation visits. You join a smaller CRO culture that emphasizes impact, collaboration, and work-life balance, with direct support from line management.
Verantwoordelijkheden
- Monitor progress of clinical studies at investigative sites to ensure conduct, recording and reporting per protocol, SOPs, ICH-GCP, and applicable regulations
- Coordinate study setup and monitoring activities (identify investigators, regulatory submissions, pre-study and initiation visits)
- Ensure study quality and timely issue mitigation through proactive risk identification and collaboration with study team
- Communicate with investigators and cross-functional teams to keep projects on track
Belangrijkste vereisten
- 2+ years as a CRA in CRO or pharmaceutical/biotech industry or equivalent
- Experience managing oncology studies
- Life science degree or equivalent
- Fluency in English and Dutch; French a plus
- Availability for 50-60% travel (domestic; international for some roles)
- Excellent communication and organizational skills; client-focused approach
- Team player and able to handle conflicts using standard resolutions
- calm and thoughtful under pressure
- proactive problem-solving
- detail-oriented
- oncology study monitoring
- site management
- regulatory submissions
Clinical Research associate II in Nederland werkgever: Jobrapido
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