FSP CRA (Level II)
Core
Monitors investigator sites using a risk-based approach to ensure data accuracy, compliance with ICH-GCP, and protocol adherence.
Role type
Clinical Research Associate (Level II)
Builds
Clinical trial sites and data integrity
Domain
Clinical Research / Life Sciences
Required skills
risk-based monitoring, root cause analysis, critical thinking, problem-solving, data review (SDR, SDV, CRF), physical inventory, regulatory compliance (ICH-GCP), site initiation, trial close out, report writing, stakeholder communication
Preferred skills
none stated
Technologies
Clinical Trial Management System (CTMS)
Responsibilities
Monitor investigator sites for compliance and data accuracy; assess investigational product inventory; document observations and escalate deficiencies; initiate and close out clinical trial sites; conduct on-site file reviews; provide trial status reports; facilitate communication between sites, client, and project team; respond to audits and inspections.
Seniority
Mid-level IC