Sr CRA I
Core
Conduct remote and on-site clinical monitoring to ensure protocol and regulatory compliance, manage site processes, and guarantee data reliability for pharmaceutical and biotech clinical trials.
Role type
Senior Clinical Research Associate (IC)
Builds
Clinical trial data integrity and regulatory compliance
Domain
Life Sciences / Clinical Research
Required skills
Clinical monitoring, Risk Based Monitoring (RBM), Root Cause Analysis (RCA), ICH-GCP compliance, Protocol adherence, Site management, Investigational product inventory, Data review (SDR/SDV/CRF), Regulatory documentation
Preferred skills
Medical/therapeutic area knowledge, Critical thinking, Problem-solving, Travel adaptability
Technologies
Clinical Trial Management Systems (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches; Conduct on-site and remote monitoring visits; Ensure audit readiness and document compliance; Manage investigator site initiation and close-out; Facilitate communication between sites, sponsors, and project teams; Respond to regulatory audits and inspections.
Seniority
Senior, hands-on IC