Senior Clinical Research Associate (Cell & Gene - FSP)
Core
Monitor clinical trial sites for Cell and Gene Therapy studies using a risk-based approach to ensure data accuracy, protocol compliance, and regulatory adherence.
Role type
Senior Clinical Research Associate (Cell & Gene Therapy)
Builds
Clinical trial data integrity and regulatory compliance for life-changing therapies
Domain
Life Sciences / Clinical Research / Cell & Gene Therapy
Required skills
Risk-based monitoring, Root cause analysis, ICH GCP knowledge, Investigational product inventory management, Clinical trial site initiation, Regulatory document management
Preferred skills
Cell and Gene Therapy experience, Medical terminology knowledge, Clinical Trial Management System proficiency
Technologies
Clinical Trial Management Systems, Microsoft Office
Responsibilities
Monitor investigator sites with a risk-based approach; Ensure data accuracy through SDR, SDV, and CRF review; Initiate clinical trial sites and conduct file reviews; Provide trial status tracking and progress reports; Respond to regulatory requirements and audits; Maintain administrative tasks like expense reports.
Seniority
Senior, hands-on IC
