FSP Sr CRA I
Core
Senior Clinical Research Associate performing risk-based monitoring, site management, and compliance assurance for clinical trials in oncology.
Role type
Senior IC clinical research associate (oncology)
Builds
Clinical trial data and regulatory compliance
Domain
Life sciences / Clinical trials
Required skills
Risk-based monitoring, Root cause analysis, Protocol compliance, ICH-GCP guidelines, Investigational product management, Clinical Trial Management Systems (CTMS), Site initiation and close-out, Regulatory documentation
Preferred skills
Oncology experience
Technologies
CTMS, Clinical Trial Management Systems
Responsibilities
Monitor investigator sites using a risk-based approach, Conduct on-site and remote monitoring visits, Ensure data accuracy through SDV and CRF review, Initiate and close out clinical trial sites, Manage investigator payments and inventory, Prepare monitoring reports and correspondence, Escalate and resolve site deficiencies, Track trial status and progress updates
Seniority
Senior, hands-on IC
