CRA (Level I)
Core
Conduct remote or 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 (Level I)
Builds
Clinical trial data and regulatory compliance for pharmaceutical/biotech sponsors
Domain
Clinical Research / Life Sciences
Required skills
Risk-Based Monitoring (RBM), ICH-GCP guidelines, protocol adherence, data review (SDR/SDV/CRF), site initiation, close-out activities, regulatory compliance, root cause analysis, problem-solving, Microsoft Office, English language proficiency
Preferred skills
Medical terminology, anatomy, clinical trial experience, travel adaptability
Technologies
Clinical Trial Management Systems (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using risk-based monitoring; ensure data accuracy through document review; assess investigational product inventory; document monitoring observations and escalate deficiencies; maintain contact with sites between visits; initiate and close-out clinical trial sites; participate in investigator meetings; track trial status and progress; ensure essential documents are complete; respond to audits and inspections; complete administrative tasks.
Seniority
Junior, entry-level IC
