FSP CRA(Level)
Core
Performs and coordinates clinical monitoring and site management processes, conducting remote or on-site visits to assess protocol and regulatory compliance for clinical trials.
Role type
Clinical Research Associate (CRA)
Builds
Clinical trial data reliability and subject safety through monitoring and site management
Domain
Life Sciences / Clinical Research
Required skills
Clinical monitoring, Risk Based Monitoring, Root Cause Analysis, ICH-GCP compliance, Site initiation, Data review (SDR/SDV/CRF), Investigational product inventory, Regulatory document management
Preferred skills
Medical/therapeutic area knowledge, Critical thinking, Problem-solving, Communication, Time management, Digital literacy
Technologies
Clinical Trial Management Systems, Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches; Conduct on-site and remote monitoring visits; Initiate clinical trial sites; Ensure audit readiness and document completeness; Track trial status and progress; Facilitate communication between sites, clients, and project teams; Perform trial close-out and material retrieval.
Seniority
Entry-level to Mid-level, hands-on IC