Clinical Research Associate I (FSP)
Core
Conduct remote and on-site clinical monitoring and site management to ensure protocol and regulatory compliance, manage documentation, and maintain audit readiness for clinical trials.
Role type
Junior Clinical Research Associate (IC)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical/biotech clients
Domain
Life Sciences / Clinical Research / Regulatory Compliance
Required skills
Clinical monitoring, Risk Based Monitoring (RBM), Root Cause Analysis (RCA), ICH-GCP guidelines, Protocol adherence, Data accuracy (SDR/SDV/CRF), Investigational product inventory, Site initiation and close-out, Regulatory compliance
Preferred skills
Medical/therapeutic area knowledge, Critical thinking, Problem-solving, Time management, Team collaboration
Technologies
Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC) systems
Responsibilities
Monitor investigator sites using a risk-based approach to identify and resolve compliance issues; Ensure data accuracy through source data review (SDR) and case report form (CRF) review; Manage investigator payments and trial close-out procedures; Initiate clinical trial sites in collaboration with client companies; Respond to regulatory audits and inspections; Provide trial status tracking and progress reports to management.
Seniority
Junior, hands-on IC