CRA II
Core
Conducts clinical monitoring and site management for global clinical trials, ensuring protocol compliance, data accuracy, and subject safety through risk-based monitoring approaches.
Role type
Clinical Research Associate (CRA) II
Builds
End-to-end clinical trial execution for commercial and government contracts
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
Risk-based monitoring, ICH-GCP guidelines, protocol compliance, data review (SDR/SDV/CRF), site initiation and close-out, root cause analysis, regulatory documentation
Preferred skills
Life sciences degree, Registered Nursing certification, medical terminology knowledge, clinical trial management systems (CTMS)
Technologies
Clinical Trial Management System (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches; ensure data accuracy through document and source data verification; initiate and close out clinical trial sites; conduct on-site file reviews; manage investigator payments; prepare reports and escalate deficiencies; facilitate communication between sites, clients, and project teams.
Seniority
Mid-level IC