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Clinical Research Associate II - Sponsor dedicated - Netherlands - Home based (m/w/d)


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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