Sr Clinical Research Associate - FSP
Core
Senior Clinical Research Associate conducting risk-based monitoring, site management, and data verification for pharmaceutical clinical trials.
Role type
Senior IC clinical research associate (monitoring)
Builds
Clinical trial data integrity and regulatory compliance
Domain
Life Sciences / Clinical Research
Required skills
Risk-based monitoring, Root cause analysis, ICH-GCP guidelines, Protocol compliance, Investigational product inventory, Site initiation, Audit readiness, Data accuracy verification
Preferred skills
Medical/therapeutic area knowledge, Clinical Trial Management Systems (CTMS), Travel adaptability
Technologies
Microsoft Office, Clinical Trial Management Systems (CTMS)
Responsibilities
Monitor investigator sites using risk-based approach; Ensure data accuracy via SDR/SDV/CRF review; Manage investigational product inventory; Initiate and close out clinical trial sites; Conduct on-site file reviews; Respond to regulatory audits/inspections; Provide trial status tracking reports.
Seniority
Senior, hands-on IC
