Sr/CRA I/II - UK (numerous locations)
Core
Conducts remote and on-site monitoring of clinical trial investigator sites to ensure protocol and regulatory compliance, data accuracy, and subject safety.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trial monitoring activities for commercial and government contracts
Domain
Clinical research / Healthcare
Deliverable
client delivery
Required skills
Risk-based monitoring, root cause analysis, protocol compliance, ICH-GCP guidelines, data verification (SDR/SDV), investigational product inventory, issue resolution, clinical trial management systems (CTMS)
Preferred skills
None stated
Technologies
Clinical Trial Management System (CTMS)
Responsibilities
Monitor investigator sites using a risk-based approach; assess protocol and regulatory compliance; ensure data accuracy through source data review; manage investigational product inventory; document observations and deficiencies; follow up on issues to resolution; provide trial status tracking reports.
Seniority
Senior, hands-on IC