Clinical Research Associate I (FSP)
Core
Conduct remote and on-site clinical monitoring to ensure protocol and regulatory compliance, manage site processes, and guarantee data reliability 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
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical monitoring, Risk Based Monitoring (RBM), Root Cause Analysis (RCA), ICH-GCP guidelines, Protocol adherence, Site management, Data review (SDR/SDV/CRF), Investigational product inventory, Regulatory compliance, Audit readiness
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 to identify and resolve compliance issues; Review source data and case report forms for accuracy; Manage site initiation and close-out processes; Escalate and track deficiencies to resolution; Conduct physical inventory of investigational products; Prepare status reports for clinical management; Respond to regulatory audits and inspections.
Seniority
Junior, hands-on IC