CRA I - Senior CRA (FSP)
Core
Performs clinical monitoring and site management for oncology clinical trials, ensuring protocol compliance and data reliability through risk-based monitoring and on-site/remote visits.
Role type
Senior Clinical Research Associate (Oncology)
Builds
Clinical trial data integrity and regulatory compliance for oncology studies
Domain
Life Sciences / Clinical Research / Oncology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk-based monitoring, Root cause analysis, Protocol compliance, ICH-GCP knowledge, Investigational product inventory, Site initiation, Trial close-out, Regulatory audit response
Preferred skills
Oncology therapeutic experience, Registered Nursing certification, Clinical Trial Management System proficiency
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 including source data verification and critical file reviews; Initiate and close out clinical trial sites; Respond to regulatory audits and inspections; Track trial status and update study systems; Facilitate communication between sites, clients, and project teams.
Seniority
Senior, hands-on IC