CRA (Level II) to Sr CRA (Level II)
Core
Conduct remote and on-site clinical monitoring visits to assess protocol and regulatory compliance, manage site documentation, and ensure data accuracy for pharmaceutical clinical trials.
Role type
Senior Clinical Research Associate (IC)
Builds
Clinical trial data integrity and regulatory compliance for top 50 pharmaceutical companies and 750+ biotechs
Domain
Life Sciences / Clinical Research
Required skills
Risk-based monitoring, root cause analysis, ICH-GCP guidelines, protocol adherence, site management, data review (SDR/SDV/CRF), investigator payment processes, trial close-out, regulatory compliance, medical terminology, travel management
Preferred skills
Bachelor's in life sciences or Registered Nursing, 2+ years clinical monitoring experience, valid driver's license, familiarity with Clinical Trial Management Systems
Technologies
Microsoft Office, Clinical Trial Management Systems
Responsibilities
Monitor investigator sites using risk-based approaches; ensure data accuracy through document review; assess investigational product inventory; escalate and resolve deficiencies; initiate and close out clinical trial sites; maintain audit readiness; facilitate communication between sites, clients, and internal teams; track trial status and progress.
Seniority
Mid-level to Senior, hands-on IC
