CRA Level II FSO
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
Preferred skills
Medical/therapeutic area knowledge, Problem-solving, Critical thinking, Team collaboration
Technologies
Clinical Trial Management Systems, Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches; Ensure data accuracy through document and source data verification; Initiate and close out clinical trial sites; Conduct on-site file reviews; Provide trial status tracking and progress reports; Respond to audits and inspections.
Seniority
Mid-level, hands-on IC