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
Mid-level Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for sponsors in pharma/biotech
Domain
Clinical Research / Life Sciences
Required skills
Clinical monitoring, Root cause analysis, Risk-based monitoring, ICH-GCP knowledge, Site initiation, Trial close-out, Data review (SDR/SDV/CRF), Investigational product inventory
Preferred skills
Oncology and Cell Therapy experience, Registered Nursing certification, PPD Drug Development Fellowship
Technologies
Clinical Trial Management Systems, Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches to identify and resolve compliance issues; Conduct on-site and remote monitoring activities including data verification 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 to management; Facilitate communication between sites, clients, and project teams.
Seniority
Junior to Mid-level, hands-on IC