FSP SCRA
Core
Senior Clinical Research Associate conducting risk-based monitoring, site management, and regulatory compliance for clinical trials in the pharmaceutical/biotech industry.
Role type
Senior Clinical Research Associate (Level I)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical and biotech sponsors
Domain
Life Sciences / Clinical Research / Regulatory Compliance
Deliverable
client delivery
Required skills
Risk-based monitoring, root cause analysis, protocol compliance, ICH-GCP guidelines, site initiation and close-out, data review (SDR/SDV/CRF), investigator management
Preferred skills
Medical/therapeutic area knowledge, travel adaptability, presentation skills
Technologies
Clinical Trial Management Systems (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches; initiate and close out clinical trial sites; ensure audit readiness and document compliance; track trial status and generate progress reports; facilitate communication between sites, clients, and project teams.
Seniority
Senior, hands-on IC
