Jobid: 3195967384 (0.11)
Overview
As a Clinical Research Associate II in IQVIA’s sponsor-dedicated model, you oversee site monitoring and ensure adherence to GCP/ICH. You collaborate with sites to drive recruitment, training, and data integrity across trials. You’ll work closely with cross-functional teams to align sponsor priorities with study execution. This role offers growth through a strong focus on career development and hands-on exposure to start-up and monitoring activities in the Netherlands.
Arbeidsvoorwaarden / Benefits
- company car or mobility allowance
- tech bundle (laptop, iPhone)
- career development and training
- home office setup support
- annual wellness reimbursement
- comprehensive time-off and leave options’,’premium pension and insurance packages
Verantwoordelijkheden
- Perform site monitoring visits (selection, initiation, monitoring, close-out) per scope and regulatory requirements
- Drive and track subject recruitment plans to meet project needs
- Administer protocol training and maintain clear communication with sites
- Assess site practices for protocol conduct and regulatory compliance; escalate issues
- Track regulatory submissions, recruitment, CRF completion, data queries, and TMF/ISF maintenance
- Prepare visit reports, follow-up letters, and other study documentation
- Collaborate with study team members for project execution
- May support start-up and recruitment plan development per site
Belangrijkste vereisten
- Bachelor’s Degree in scientific discipline or health care
- 18 months on-site CRA monitoring experience in CRO or pharmaceutical environment
- Fluency in Dutch (C1) and English; strong medical writing skills
- Solid knowledge of GCP and ICH guidelines
- Strong organizational and problem-solving skills
- Excellent interpersonal and cross-cultural communication; collaborative mindset
- interpersonal communication
- cross-cultural adaptability
- problem-solving
- GCP/ICH knowledge
- site management and monitoring
- regulatory submissions tracking
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