Clinical Research Associate (Level II)
Core
Coordinate clinical monitoring and site management to ensure protocol and regulatory compliance across global trials.
Role type
Clinical Research Associate (Level II)
Builds
Clinical trials for pharmaceutical and biotech sponsors
Domain
Life Sciences / Clinical Research
Deliverable
client delivery
Required skills
Risk-based monitoring, root cause analysis, data review (SDR/SDV/CRF), investigator site initiation, trial close-out, ICH-GCP compliance, regulatory audit response
Preferred skills
Medical/therapeutic area knowledge, Clinical Trial Management System (CTMS) proficiency, travel adaptability
Technologies
Microsoft Office, Clinical Trial Management Systems
Responsibilities
Monitor investigator sites using risk-based approaches to identify and resolve compliance issues; Conduct on-site and remote monitoring including data accuracy checks and inventory reviews; Initiate and close out clinical trial sites; Ensure essential documents and study systems are up to date; Facilitate communication between sites, clients, and project teams; Respond to regulatory audits and inspections.
Seniority
Mid-level, hands-on IC