CRA (Level II)
Core
Performs clinical monitoring and site management to ensure trial compliance with ICH-GCP guidelines and regulations, managing documentation and site processes.
Role type
Level II Clinical Research Associate (CRA)
Builds
Clinical trial data reliability and regulatory compliance for pharmaceutical/medical device sponsors
Domain
Clinical Research / Life Sciences
Required skills
Risk-based monitoring, Root cause analysis, Protocol compliance, ICH-GCP knowledge, Site initiation, Data review (SDR/SDV/CRF), Investigational product inventory, Regulatory audit response, Clinical trial close-out
Preferred skills
Medical/therapeutic area knowledge, Microsoft Office proficiency, English language proficiency
Technologies
Clinical Trial Management Systems (CTMS)
Responsibilities
Monitor investigator sites using risk-based approaches; Conduct on-site and remote monitoring visits; Initiate and close out clinical trial sites; Ensure document completeness and audit readiness; Track trial status and progress; Facilitate communication between sites, clients, and project teams.
Seniority
Junior, entry-level IC