Senior Clinical Research Associate I (FSP)
Core
Performs and coordinates clinical monitoring and site management processes to ensure protocol and regulatory compliance, guaranteeing subject rights and data reliability.
Role type
Senior Clinical Research Associate (Monitoring)
Builds
Clinical trials for life sciences and healthcare clients
Domain
Life Sciences / Clinical Research
Required skills
Risk-based monitoring, root cause analysis, protocol compliance, ICH-GCP guidelines, site initiation, data review (SDR/SDV/CRF), investigator management, audit readiness, regulatory documentation
Preferred skills
Medical/therapeutic area knowledge, problem-solving, digital literacy
Technologies
Clinical Trial Management Systems, Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches; initiate and close out clinical trial sites; conduct on-site and remote monitoring activities; ensure document completeness per ICH-GCP; track trial status and provide progress reports; respond to audits and inspections.
Seniority
Senior, hands-on IC