Clinical Research Associate I
Core
Coordinate clinical monitoring and site management to ensure trial compliance with protocols, ICH-GCP guidelines, and regulations while guaranteeing subject rights and data reliability.
Role type
Clinical Research Associate (Level II)
Builds
Clinical trials for pharmaceutical and biotech sponsors
Domain
Clinical research / Life sciences
Deliverable
client delivery
Required skills
Clinical monitoring, Risk Based Monitoring (RBM), Root Cause Analysis (RCA), protocol compliance, ICH-GCP knowledge, site initiation, trial close out, data review (SDR/SDV/CRF), regulatory audit response
Preferred skills
Medical/therapeutic area knowledge, problem-solving, critical thinking, travel adaptability
Technologies
Clinical Trial Management Systems (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches; initiate and close out clinical trial sites; ensure document completeness and audit readiness; track trial status and provide progress reports; facilitate communication between sites, clients, and project teams; respond to regulatory audits and inspections.
Seniority
Entry-level (1 year experience or fellowship equivalent)