Maintaining significant knowledge in regulatory requirements and ICH GCP principles.
Preparing audit plans for individual audits and audit/risk mitigation plans for larger projects and programs, as needed.
Leading and/or assisting with audit activities including sponsor audits, clinical site audits, key document audits and software and system validation documentation audits.
Conducting audits of clinical trial vendors providing services such as central imaging, central laboratory services, ECG, IP management and distribution, IRB review, and EDC, as required.
Evaluating internal compliance with company procedures, policies, programs, initiatives, GCP, and applicable regulations.
Assisting the organization in preparation for, coordination, hosting, conduct, documentation and follow-up of regulatory inspections.
Using a risk-based approach in the identification of audit candidates and the evaluation of personnel, facilities, documents, processes and systems.
Assisting in the creation, review, revision and management of procedural documents.
Clearly communicating and reporting (verbally and in writing) audit outcomes and escalating significant compliance concerns to project teams, QA and Rho management and sponsor contacts appropriately.
Providing regulatory compliance guidance and quality improvement consult to internal and external customers.
Employing risk identification and mitigation strategies related to identified and potential compliance issues.
Reporting, managing and following deviations, complaints, issues, non-conformances and their related CAPAs.
Assisting in the management of contract auditors.
Modeling Rho’s Core Values.
Supporting business proposal preparation and defense.
Preparing training materials and conducting training related to relevant QA topics.