FSP Sr CRA (Level I)
Core
Senior Clinical Research Associate conducting risk-based monitoring, site management, and audit readiness for oncology and cell therapy clinical trials.
Role type
Senior Clinical Research Associate (Level I)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical and biotech sponsors
Domain
Life Sciences / Clinical Research / Oncology / Cell Therapy
Required skills
Risk-based monitoring, Root cause analysis, ICH-GCP compliance, Protocol adherence, Site initiation, Trial close-out, Investigational product inventory, Regulatory documentation, Clinical trial management systems, Oncology and cell therapy knowledge
Preferred skills
None stated
Technologies
Clinical Trial Management Systems (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches to ensure protocol and regulatory compliance; Conduct on-site and remote monitoring including source data verification and critical file review; Initiate and close out clinical trial sites; Manage investigator payments and ensure essential document completeness; Respond to audits and inspections; Track trial status and generate progress reports; Facilitate communication between sites, clients, and project teams.
Seniority
Senior, hands-on IC