Clinical Research Associate (CRA level I) - FSP
Core
Monitor clinical trial investigator sites using a risk-based approach to ensure compliance with protocols and regulations, ensuring data accuracy and product integrity.
Role type
Junior Clinical Research Associate (CRA Level I)
Builds
Clinical trial data and site compliance for pharmaceutical/biotech clients
Domain
Clinical Research / Life Sciences
Required skills
Risk-based monitoring, Root cause analysis, Data verification (SDR/SDV), Investigational product inventory, Regulatory compliance (ICH-GCP, FDA, EU), Site initiation and close-out, Report writing
Preferred skills
Medical/therapeutic area knowledge, CRA experience across all study phases
Technologies
Clinical Trial Management Systems, Microsoft Office
Responsibilities
Monitor investigator sites with a risk-based monitoring approach; Ensure data accuracy through SDR, SDV and CRF review; Assess investigational product through physical inventory and records review; Document observations in reports and letters; Escalate observed deficiencies and issues to clinical management; Participate in investigator meetings and site identification; Initiate clinical trial sites and perform trial close out; Provide trial status tracking and progress update reports.
Seniority
Junior, hands-on IC
