Clinical Research associate II

Over de vacature

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

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