Overview
In this Senior CRA role, you will lead on-site monitoring within our sponsor-dedicated model in the Netherlands, ensuring GCP/ICH compliance and high-quality site performance. You will partner with sites and cross-functional teams to drive subject recruitment, training, and issue resolution, shaping study delivery. The position emphasizes collaboration, career development, and direct sponsor interactions. This is an opportunity to impact trial quality and timelines in a global CRO setting.
Arbeidsvoorwaarden / Benefits
- company car or mobility allowance
- laptop and iPhone
- career development programs
- home office setup support
- annual wellness reimbursement
- pension plan and corporate insurance
Verantwoordelijkheden
- Perform site monitoring visits (selection, initiation, monitoring, close-out) per scope and regulatory requirements (GCP/ICH)
- Drive and track subject recruitment plans aligned with project needs
- Administer protocol training to sites and maintain regular communication to manage expectations
- Evaluate site practices for protocol conduct and regulatory adherence; escalate quality issues
- Track regulatory submissions, recruitment, CRF completion, data queries; may support start-up
- Ensure TMF/ISF documentation is complete and compliant
- Create and maintain site management documentation and submit visit reports and follow-up letters
- Collaborate with study team for project execution support
- Possibly support development of site-specific recruitment plans
- Maintain documentation of monitoring findings and action plans
Belangrijkste vereisten
- 3+ years of on-site monitoring experience as a CRA in CRO or pharmaceutical environment
- Dutch (C1) and English (professional fluency) with strong medical writing skills
- Knowledge of GCP and ICH guidelines
- Organizational and problem-solving abilities
- Excellent interpersonal and cross-cultural communication skills
- Collaborative mindset for cross-functional global teams and local coordinators
- interpersonal communication
- cross-cultural collaboration
- problem-solving
- GCP/ICH knowledge
- on-site monitoring
- CRF data handling and query resolution
Senior Clinical Research Associate - Sponsor dedicated - Netherlands - Home based (m/w/d) in Amsterdam werkgever: Jobrapido
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