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Astrix · 1 day ago

GCP Auditor

United States

Full-time

Remote

Mid, Senior Level

$100K/yr - $150K/yr

4+ years exp

Astrix is partnering with an innovative client in the biotechnology industry, seeking a Clinical Compliance Auditor to ensure the highest standards in clinical trials. The role involves overseeing the Clinical Trial Quality Management system, creating and evaluating SOPs, and conducting audits to ensure compliance with industry standards.

ConsultingInformation Technology

Growth Opportunities

Responsibilities

Oversee and regularly update the Clinical Trial Quality Management system to ensure alignment with current industry standards, guidelines, and best practices

Assist in the creation and evaluation of standard operating procedures (SOPs) and other essential controlled documents, such as forms, templates, and work instructions

Ensure adherence to SOPs and compliance with relevant standards, including ICH GCP E6 (R2)

Lead the incident management process by tracking and addressing complaints, deviations, and corrective actions (CAPAs)

Organize, coordinate, and execute audits of vendors, suppliers, clinical trial sites, as well as internal and compliance audits, including for-cause audits

Prepare necessary documentation to support audit activities, including audit plans, reports, certificates, and corrective action plans

Verify the accuracy of audit findings and follow-up activities, ensuring non-compliance issues are resolved appropriately

Review and finalize audit reports for accuracy and completeness

Examine trial-related documents such as protocols, amendments, informed consent forms (ICFs), pharmacy manuals, and clinical study reports (CSRs)