Clinical Research Associate (Level I or II)
Core
Conduct remote or on-site clinical monitoring and site management to ensure trial compliance with protocols, ICH-GCP guidelines, and regulations.
Role type
Clinical Research Associate (Level I or II)
Builds
Clinical trials for pharmaceutical/biotech sponsors
Domain
Life Sciences / Clinical Research
Required skills
Clinical monitoring, Risk Based Monitoring (RBM), Root Cause Analysis (RCA), Protocol compliance, ICH-GCP knowledge, Data review (SDR/SDV/CRF), Investigational product inventory, Site initiation, Trial close-out, Regulatory audit response
Preferred skills
Medical/therapeutic area knowledge, Critical thinking, Problem-solving, Time management, Team collaboration
Technologies
Clinical Trial Management Systems (CTMS)
Responsibilities
Monitor investigator sites using risk-based approaches; Ensure data accuracy through document and source data verification; Manage site initiation and trial close-out processes; Respond to regulatory audits and inspections; Track trial status and provide progress reports; Facilitate communication between sites, clients, and project teams.
Seniority
Entry to Mid-level, hands-on IC