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 (Level I)
Builds
Clinical trial data reliability and subject safety
Domain
Pharmaceutical/Biotech clinical research
Required skills
Risk-based monitoring, root cause analysis, data verification (SDR/SDV/CRF), ICH-GCP compliance, site initiation, trial close-out, regulatory document management
Preferred skills
Medical terminology, anatomy knowledge, clinical trial management systems
Technologies
Clinical Trial Management Systems, Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches; ensure data accuracy through document review; initiate and close out clinical trial sites; maintain essential study documents; provide trial status reports; facilitate communication between sites, clients, and internal teams.
Seniority
Junior, entry-level IC