Sr. CRA (Level 1)
Core
Conduct remote and on-site clinical monitoring to ensure protocol and regulatory compliance, manage site processes, and guarantee data reliability for pharmaceutical and biotech clinical trials.
Role type
Senior Clinical Research Associate (Level I)
Builds
Clinical trial data integrity and regulatory compliance for sponsors
Domain
Life Sciences / Clinical Research
Deliverable
client delivery
Required skills
Risk-based monitoring, root cause analysis, ICH-GCP guidelines, clinical monitoring, medical terminology, regulatory compliance, site initiation, audit readiness
Preferred skills
Therapeutic area knowledge, problem-solving, travel adaptability
Technologies
Clinical Trial Management System (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches; review data accuracy via SDR/SDV/CRF; initiate and close out clinical trial sites; ensure document completeness per regulations; track trial status and update study systems; facilitate communication between sites, clients, and project teams.
Seniority
Senior, hands-on IC
