CRA (Level 1)
Core
Conduct remote and on-site clinical monitoring visits to assess protocol and regulatory compliance, manage site processes, and ensure data reliability for clinical trials.
Role type
Level 1 Clinical Research Associate (IC)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical and biotech sponsors
Domain
Life Sciences / Clinical Research
Deliverable
client delivery
Required skills
Risk-based monitoring, root cause analysis, critical thinking, problem-solving, data verification (SDR/SDV/CRF), investigational product inventory, ICH-GCP knowledge, regulatory compliance, site initiation, trial close-out, document management
Preferred skills
Medical terminology, anatomy, clinical trial management systems (CTMS), Microsoft Office
Technologies
Clinical Trial Management System, Microsoft Office
Responsibilities
Monitor investigator sites using a risk-based approach to identify and resolve compliance issues; verify data accuracy through on-site and remote monitoring; initiate and close out clinical trial sites; conduct on-site file reviews; track trial status and generate progress reports; facilitate communication between sites, clients, and internal teams; manage administrative tasks like expense reports and timesheets.
Seniority
Junior, hands-on IC