Sr/CRA I/II - UK (numerous locations)
Core
Conducts remote and on-site clinical monitoring of investigator sites to ensure protocol and regulatory compliance, data accuracy, and subject safety across commercial and government contracts.
Role type
Senior Clinical Research Associate (CRA)
Builds
End-to-end clinical trial execution from study start-up to close-out
Domain
Clinical Research / Life Sciences
Required skills
Clinical monitoring, Risk Based Monitoring (RBM), Root Cause Analysis (RCA), ICH-GCP guidelines, Protocol adherence, Investigational product management, Site initiation and close-out, Data review (SDR/SDV/CRF), Regulatory compliance
Preferred skills
Medical/therapeutic area knowledge, Critical thinking, Problem-solving, Microsoft Office proficiency
Technologies
Clinical Trial Management Systems (CTMS), Microsoft Office
Responsibilities
Perform risk-based monitoring visits to assess compliance and identify corrective actions; Ensure data accuracy through source data review and CRF reconciliation; Manage investigator site initiation, payment processes, and trial close-out; Maintain audit readiness and respond to regulatory inspections; Collaborate with project teams and clients to resolve issues and track trial progress.
Seniority
Mid-level, hands-on IC