CRA (Level II)
Core
Conducts remote and on-site clinical monitoring and site management to ensure protocol and regulatory compliance, manage documentation, and guarantee subject rights and data reliability for clinical trials.
Role type
Level II Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical/biotech sponsors
Domain
Life Sciences / Clinical Research / Pharmaceutical
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk-based monitoring, root cause analysis, critical thinking, problem-solving, ICH-GCP knowledge, regulatory compliance, site initiation, trial close-out, data review (SDR/SDV/CRF), investigator payment processing, document management, clinical trial system updates
Preferred skills
Life sciences degree or Registered Nursing certification, medical/therapeutic area knowledge, Microsoft Office proficiency, English language proficiency, presentation skills
Technologies
Clinical Trial Management Systems (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches; conduct on-site and remote monitoring activities; initiate clinical trial sites; perform trial close-out and material retrieval; respond to audits and inspections; provide trial status reports; facilitate communication between sites, clients, and project teams.
Seniority
Junior, hands-on IC