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 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 / Oncology / Cell Therapy
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 completion
Technologies
Clinical Trial Management Systems, Microsoft Office
Responsibilities
Monitor investigator sites using a risk-based approach to identify and resolve compliance issues; Conduct on-site and remote monitoring activities including data review and inventory checks; Initiate clinical trial sites and perform trial close-out procedures; Ensure essential documents are complete and audit-ready; Provide trial status tracking and progress reports to management; Respond to regulatory audits and inspections.
Seniority
Mid-level, hands-on IC