CRA (Level I)
Core
Conduct remote and on-site clinical monitoring and site management to ensure protocol compliance, data accuracy, and subject safety across FSO, FSP, and Government environments.
Role type
Junior Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical/biotech sponsors
Domain
Clinical Research / Life Sciences
Required skills
Risk-Based Monitoring (RBM), Source Data Verification (SDV), Critical thinking, Root cause analysis, ICH-GCP knowledge, Protocol adherence, Investigational product inventory, Regulatory compliance, Clinical Trial Management Systems (CTMS), Medical terminology
Preferred skills
None stated
Technologies
Clinical Trial Management Systems (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using a risk-based approach; Ensure data accuracy through SDR, SDV, and CRF review; Assess investigational product through physical inventory and records review; Document monitoring observations and escalate deficiencies; Maintain contact with sites between visits; Initiate clinical trial sites; Perform trial close-out activities; Ensure essential documents are complete; Provide trial status tracking; Respond to audits and inspections.
Seniority
Junior, entry-level IC