CRA (Level II)
Core
Performs clinical monitoring and site management to ensure protocol compliance, data accuracy, and regulatory adherence for global medical research trials.
Role type
Level II Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for investigational sites
Domain
Clinical research / Life sciences
Deliverable
client delivery
Required skills
Source document verification, Investigational product inventory management, Deficiency escalation and resolution, Clinical Trial Management System (CTMS) usage, Site initiation and close-out procedures, Regulatory compliance (ICH GCP/FDA)
Preferred skills
Medical/therapeutic area knowledge, GCP/SOP knowledge, Customer focus, Organizational skills, Microsoft Office proficiency
Responsibilities
Monitor investigator sites for CRF accuracy and source document verification, Assess investigational product through physical inventory, Initiate and close out clinical trial sites, Manage essential trial documents, Provide trial status tracking reports, Respond to regulatory audits
Seniority
Junior, hands-on IC