Clinical Research Associate Level II
Core
Coordinate clinical monitoring and site management to ensure protocol and regulatory compliance, guaranteeing subject rights and data reliability.
Role type
Clinical Research Associate (Level II)
Builds
Clinical trials for pharmaceutical and biotech sponsors
Domain
Clinical research / Life sciences
Required skills
Clinical monitoring, Risk Based Monitoring (RBM), Root Cause Analysis (RCA), ICH-GCP knowledge, Protocol adherence, Site initiation, Trial close-out, Data review (SDR/SDV/CRF), Investigational product inventory
Preferred skills
Medical/therapeutic area knowledge, Critical thinking, Problem-solving, Team collaboration
Technologies
Clinical Trial Management Systems (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches; Conduct on-site and remote monitoring visits; Initiate and close out clinical trial sites; Ensure audit readiness and document compliance; Facilitate communication between sites, clients, and project teams; Respond to regulatory audits and inspections.
Seniority
Mid-level, hands-on IC