FSP Sr Clinical Research Associate
Core
Performs and coordinates clinical monitoring and site management to ensure protocol and regulatory compliance, guaranteeing subject rights and data reliability.
Role type
Senior Clinical Research Associate (Sr CRA)
Builds
Clinical trial data and compliance
Domain
Life Sciences / Clinical Research
Required skills
Risk-based monitoring, Root cause analysis, ICH-GCP guidelines, Protocol adherence, Investigational product inventory, Data accuracy review, Site initiation, Trial close out, Regulatory compliance, Critical thinking
Preferred skills
Medical/therapeutic area knowledge, Microsoft Office, Presentation skills
Technologies
Clinical Trial Management System (CTMS)
Responsibilities
Monitor investigator sites with a risk-based approach, Ensure data accuracy through SDR/SDV/CRF review, Conduct on-site file reviews, Initiate and close out clinical trial sites, Escalate deficiencies to clinical management, Participate in investigator meetings, Maintain trial status tracking reports
Seniority
Senior, hands-on IC