Lead CRA/ Principal CRA
ICON · Blue Bell
Clinical OperationsFull-timeCompany career page
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Role summary
ICON Strategic Solutions seeks an experienced Lead Clinical Research Associate for oncology trials in a sponsor-dedicated model. The role involves overseeing clinical site engagement and monitoring activities, mentoring CRAs, and ensuring trial conduct quality and regulatory compliance across a regional territory.
What they're looking for
- Bachelor's degree in scientific or clinical field; advanced degree preferred
- 8+ years oncology monitoring experience with minimum 4 years in Phase I or Phase III trials
- Demonstrated experience conducting on-site and remote monitoring visits independently
- Proficiency with Veeva CTMS and Trial Master File systems
- Strong knowledge of Good Clinical Practice and clinical trial regulations
- Site and/or sponsor inspection support experience preferred
What you'll be doing
- Develop and maintain strong relationships with clinical trial sites to support enrollment and study milestone progression
- Conduct monitoring oversight visits to assess FSP CRA quality and ensure inspection readiness
- Execute site qualification, initiation, interim monitoring and close-out visits; train and onboard CRAs
- Review monitoring visit reports, site KRI metrics, and audit Trial Master Files to detect and resolve issues
- Train CRAs and sites on GCP, protocols, and study-specific requirements; manage corrective and preventive actions
Privacy & handoff
This role links to ICON's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.