Senior Clinical Research Associate, Sponsor Aligned, Oncology
IQVIA · Overland Park, KS +1 more
Clinical OperationsFull-time$72k–$189kCompany career page
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Role summary
IQVIA seeks a Senior Clinical Research Associate to oversee oncology trial sites, ensuring protocol compliance and regulatory adherence. The role involves site monitoring, recruitment support, training, and quality assurance for Phase 1 cancer studies across multiple locations.
What they're looking for
- Bachelor's degree required; scientific or healthcare discipline preferred
- 3+ years on-site oncology monitoring experience strongly preferred, or 1.5+ years considered
- Phase 1 oncology trial experience required
- Proficiency in GCP and ICH guidelines
- Strong protocol knowledge and therapeutic expertise in Phase 1 oncology
- Proficient with Microsoft Office and mobile devices
- Excellent communication, organizational, and problem-solving skills
What you'll be doing
- Conduct site selection, initiation, monitoring, and close-out visits per GCP and ICH standards
- Collaborate with sites on recruitment planning and tracking to meet enrollment targets
- Deliver protocol training and maintain regular site communication to manage expectations
- Assess site compliance with study protocols and regulatory requirements, escalating issues
- Oversee regulatory submissions, data queries, CRF completion, and documentation in TMF and ISF
Key requirements
- Therapeutic area
- Oncology
Privacy & handoff
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