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
Clinical Research Associate (Level II)
Builds
Clinical trial data and compliance reports for pharmaceutical and biotech sponsors
Domain
Life Sciences / Clinical Research
Required skills
Clinical monitoring, Root cause analysis, Risk-based monitoring, ICH-GCP knowledge, Site initiation, Data review (SDR/SDV/CRF), Investigational product inventory, Regulatory compliance, Travel management
Preferred skills
Oncology experience, Cell therapy knowledge, PPD Drug Development Fellowship, Registered Nursing certification
Technologies
Clinical Trial Management Systems, Microsoft Office
Responsibilities
Monitor investigator sites using a risk-based approach to identify and resolve compliance issues; Ensure data accuracy through source data review and case report form verification; Initiate and close out clinical trial sites; Conduct on-site file reviews and physical inventory checks; Facilitate communication between sites, clients, and project teams; Respond to audits and inspections; Perform frequent travel (60-80%) to site locations.