CRA (Level II)
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
Clinical Research Associate II (IC)
Builds
Clinical trial execution and site compliance for top 50 pharmaceutical companies and 750+ biotechs
Domain
Life Sciences / Clinical Research
Deliverable
client delivery
Required skills
Risk-based monitoring, root cause analysis, critical thinking, problem-solving, data accuracy verification (SDR/SDV/CRF), investigational product inventory, audit readiness, ICH-GCP knowledge, regulatory compliance, site initiation, trial close-out, essential document management, clinical trial management systems
Preferred skills
Medical/therapeutic area knowledge, medical terminology, travel adaptability, team collaboration
Technologies
Clinical Trial Management Systems, Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches to identify failures and implement corrective actions; ensure data accuracy through source data review and CRF checks; conduct physical inventory and records review of investigational products; document observations and escalate deficiencies to clinical management; initiate clinical trial sites and perform trial close-out; maintain essential documents and conduct on-site file reviews; provide trial status tracking and progress reports; facilitate communication between sites, clients, and internal teams; complete administrative tasks like expense reports and timesheets.
Seniority
Mid-level, hands-on IC