Overview
In this Sponsor-dedicated CRA role, you monitor clinical sites to ensure GCP/ICH compliance and data integrity, collaborating with Dutch investigators and global teams. You’ll support site recruitment planning, training, and documentation, helping sponsor programs run smoothly and meet project milestones. The position emphasizes hands-on site engagement, quality oversight, and cross-functional teamwork in a dynamic environment. This is a chance to advance in a client-focused CRO setting while shaping sponsor-specific research delivery.
Arbeidsvoorwaarden / Benefits
- company car or flexible mobility allowance
- laptop and iPhone
- dedicated training programs
- home office setup support
- annual wellness reimbursement
- flexible vacation and year-end leave options
Verantwoordelijkheden
- Conduct site monitoring visits (selection, initiation, monitoring, close-out) per scope of work and regulatory requirements
- Support and drive subject recruitment plans aligned with project needs
- Deliver protocol-related training to sites and maintain open communication channels
- Assess site practices for protocol adherence and regulatory compliance; escalate quality issues
- Track regulatory submissions, approvals, recruitment, CRF completion, data queries, and study progress
- Ensure availability and filing of TMF site documents and ISF maintenance per GCP/local regulations
- Create documentation on site management, monitoring findings, and action plans; prepare visit reports and follow-up
- Collaborate with study team members for project execution and, where applicable, support site recruitment planning
Belangrijkste vereisten
- Bachelor's Degree in scientific discipline or health care
- Minimum 6 months of independent on-site monitoring experience in CRO or pharmaceutical environment
- Full professional fluency in Dutch (C1) and English, with strong medical writing skills
- Solid knowledge of GCP and ICH guidelines
- Strong organizational and problem-solving skills
- Exceptional interpersonal and cross-cultural communication skills with site investigators and staff
- Collaborative mindset for working with cross-functional global teams, PMs, and local coordinators
- interpersonal skills
- cross-cultural communication
- collaborative mindset
- GCP and ICH knowledge
- medical writing skills
- regulatory submission tracking
Clinical Research Associate I - Sponsor dedicated - Netherlands - Home based (m/w/d) in Amsterdam werkgever: Jobrapido
StarPark is een uitstekende werkgever die je de kans biedt om te werken op diverse evenementen en festivals, waar je in een informele en prettige werksfeer kunt bijdragen aan de veiligheid van bezoekers. Met flexibele werkmogelijkheden en goede begeleiding vanuit het team, stimuleert StarPark persoonlijke groei en ontwikkeling, waardoor je niet alleen waardevolle ervaring opdoet, maar ook de mogelijkheid hebt om door te groeien binnen de organisatie. Wij verwelkomen iedereen, ongeacht achtergrond, en geloven dat jouw talent het belangrijkste is.
