Sr Clinical Research Associate FSP
Core
Senior Clinical Research Associate conducting risk-based monitoring, site management, and compliance assurance for clinical trials.
Role type
Senior Clinical Research Associate (Level I)
Builds
Clinical trial data reliability and regulatory compliance for pharmaceutical and biotech clients
Domain
Clinical Research / Life Sciences
Deliverable
physical/clinical work
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, Critical thinking, Problem-solving
Technologies
Clinical Trial Management System (CTMS)
Responsibilities
Monitor investigator sites using risk-based approaches; Ensure data accuracy through document and record review; Initiate and close out clinical trial sites; Manage investigator payments and meetings; Respond to audits and regulatory inspections; Track trial status and update study systems.
Seniority
Senior, hands-on IC