FSP 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
Level II Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for sponsors in pharma/biotech
Domain
Clinical Research / Life Sciences
Required skills
Risk-based monitoring, root cause analysis, critical thinking, problem-solving, ICH-GCP knowledge, regulatory compliance, site management, data accuracy verification (SDR/SDV/CRF), investigator site identification, trial close-out, administrative reporting
Preferred skills
Oncology and Cell Therapy experience, Registered Nursing certification, familiarity with Clinical Trial Management Systems
Technologies
Microsoft Office, Clinical Trial Management Systems
Responsibilities
Monitor investigator sites using risk-based approaches to identify and resolve compliance issues; conduct on-site and remote monitoring activities including data review and inventory checks; initiate and close out clinical trial sites; ensure essential documents are complete and audit-ready; track trial status and provide progress reports; facilitate communication between sites, clients, and project teams; respond to audits and inspections.
Seniority
Mid-level, hands-on IC