Sr CRA (Level II)
Core
Conducts remote and on-site clinical monitoring and site management to ensure protocol and regulatory compliance, guaranteeing subject rights and data reliability.
Role type
Senior Clinical Research Associate (Level II)
Builds
Clinical trial data and compliance for pharmaceutical/biotech clients
Domain
Clinical Research / Life Sciences
Required skills
Risk-based monitoring, Root cause analysis, Protocol compliance, ICH-GCP guidelines, Site initiation, Data review (SDR/SDV/CRF), Investigational product inventory, Audit readiness, Mentoring junior staff
Preferred skills
Clinical trial management systems (CTMS), Process improvement, Cross-functional collaboration
Technologies
Clinical Trial Management Systems (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches; Conduct on-site and remote monitoring visits; Initiate clinical trial sites; Ensure audit readiness and document completeness; Mentor new team members; Track trial status and progress reports.
Seniority
Senior, hands-on IC