CRA (Level I)
Core
Conduct remote or on-site clinical monitoring visits to assess protocol and regulatory compliance, manage documentation, and ensure audit readiness for clinical trials.
Role type
Junior Clinical Research Associate (IC)
Builds
Clinical trial data reliability and regulatory compliance
Domain
Pharmaceutical/Biotech clinical research
Required skills
Risk-based monitoring, Root cause analysis, Data verification (SDR/SDV/CRF), ICH-GCP guidelines, Protocol adherence, Investigational product inventory, Regulatory compliance, Site initiation, Trial close-out, Clinical Trial Management Systems
Preferred skills
Life sciences background, Medical terminology, Risk management concepts, Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches, Ensure data accuracy through document review, Conduct on-site file reviews, Initiate clinical trial sites, Perform trial close-out and material retrieval, Provide trial status tracking reports, Respond to regulatory audits and inspections
Seniority
Junior, entry-level IC