CRA (Level Ⅱ）
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
Level II Clinical Research Associate (IC)
Builds
Clinical trial data integrity and regulatory compliance for sponsors
Domain
Life Sciences / Clinical Research
Deliverable
client delivery
Required skills
Clinical monitoring, Risk Based Monitoring (RBM), Root Cause Analysis (RCA), ICH-GCP knowledge, Protocol adherence, Site management, Investigational product inventory, Regulatory compliance
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; Ensure data accuracy via SDV/SDR/CRF review; Manage site initiation, close-out, and essential document completion; Facilitate communication between sites, clients, and project teams; Respond to audits and inspections; Perform travel to site locations (60-80% travel).