Senior Clinical Research Associate I
Core
Conducts remote and on-site clinical monitoring and site management to ensure protocol and regulatory compliance, data accuracy, and subject safety in Phase I healthy volunteer studies.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical/biotech sponsors
Domain
Clinical Research / Life Sciences
Deliverable
physical/clinical work
Required skills
Risk-based monitoring, Root cause analysis (RCA), Protocol compliance, ICH-GCP guidelines, Investigational product inventory, Clinical Trial Management Systems (CTMS), Phase I study experience
Preferred skills
Registered Nursing certification, Life sciences degree, Medical terminology knowledge
Technologies
Microsoft Office, Clinical Trial Management Systems (CTMS)
Responsibilities
Monitor investigator sites using risk-based approaches; Conduct on-site and remote file reviews; Ensure audit readiness and document essential documents; Initiate and close out clinical trial sites; Track trial status and update study systems; Facilitate communication between sites, clients, and project teams.
Seniority
Senior, hands-on IC