FSP Sr CRA (Level I)
Core
Senior Clinical Research Associate conducting risk-based monitoring, site initiation, and close-out for oncology clinical trials.
Role type
Senior Clinical Research Associate (Level I)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical sponsors
Domain
Life Sciences / Clinical Research / Oncology
Required skills
Risk-based monitoring, Root cause analysis, Protocol compliance, ICH-GCP guidelines, Site initiation, Trial close-out, Investigational product inventory, Data review (SDR/SDV/CRF), Regulatory audit response
Preferred skills
Oncology therapeutic area experience, Rare diseases, Neurology
Technologies
Clinical Trial Management Systems (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approach to ensure protocol and regulatory compliance; Initiate and close out clinical trial sites; Conduct on-site and remote monitoring activities including data review and inventory checks; Respond to regulatory audits and inspections; Track trial status and update study systems; Collaborate with project teams on process improvement and publications.
Seniority
Senior, hands-on IC
