Clinical Research Associate I (FSP)
Core
Conduct remote and on-site clinical monitoring and site management to ensure protocol and regulatory compliance 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
Required skills
Clinical monitoring, Root cause analysis, Risk-based monitoring, ICH-GCP knowledge, Data accuracy 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, Travel adaptability
Technologies
Clinical Trial Management Systems (CTMS)
Responsibilities
Monitor investigator sites using risk-based approaches; Review data accuracy via SDR, SDV, and CRF; Manage site initiation and trial close-out; Ensure audit readiness and document compliance; Escalate and resolve site deficiencies; Track trial status and progress reports.
Seniority
Junior, hands-on IC