Senior Clinical Research Associate (Cell & Gene - FSP)
Core
Monitor clinical trial sites for Cell and Gene Therapy studies, ensuring compliance with ICH-GCP and protocol adherence through risk-based monitoring, data review, and site initiation.
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 compliance, Site initiation, Data accuracy review, Investigational product inventory, Regulatory audit response
Preferred skills
Cell and Gene Therapy experience, Clinical trial management systems, Medical terminology knowledge
Technologies
Clinical Trial Management Systems, Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches; Initiate and close out clinical trial sites; Conduct on-site file reviews; Track trial status and update study systems; Respond to regulatory audits and inspections.
Seniority
Senior, hands-on IC
