Univ – Quality Assurance Auditor and Education Specialist

Univ – Quality Assurance Auditor and Education Specialist

Requirements

• In-depth knowledge of federal, state, institutional, IRB, and CTO regulations and policies
• Strong understanding of FDA, GCP, and ICH regulations
• Exceptional attention to detail
• Ability to work independently with minimal supervision
• Effective verbal and written communication skills
• Clinical research, quality assurance, or regulatory compliance in human subject clinical trials
• Knowledge of the clinical research audit process, sponsor monitoring, and performance reporting in a clinical research setting
• Experience in the development of training materials, SOPs, and quality assurance documentation
• Ability to work effectively with cross-functional teams and manage multiple priorities
• Experience in leading or supporting process improvement projects or pilots
• Strong interpersonal skills with the ability to collaborate effectively across departments and resolve study-related concerns

Responsibilities

• Conduct various human subject clinical trial audits within the CTO to ensure protocol compliance
• Audit national cooperative group clinical trials, Phase II trials, high-risk trials, and potential FDA registration trials
• Conduct new employee subject enrollment audits focusing on Good Clinical Practice (GCP), IRB SOPs, and CTO best practices
• Perform internal reviews in preparation for NCI National Clinical Trials Network (NCTN) audits, MUSC compliance checks, and sponsor quality control visits
• Complete audit reports using standard report templates in a timely and accurate manner
• Communicate findings to QAE Program Manager and enter findings within the clinical trials management system
• Collaborate with the QAE Program Manager to onboard and train CTO staff on Standard Operating Procedures (SOPs), MUSC IRB policies, Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs), and ICH Guidelines
• Ensure patient eligibility and safety, data integrity, and oncology protocol compliance
• Conduct training and education for staff on subject research chart organization, CTSU Open patient registration, Medidata Rave, TRIAD, electronic patient reported outcomes (ePRO), adverse events, response evaluation criteria in solid tumors (RECIST), NCI Specimen tracking systems, research compliance, CTO policies and federal guidelines
• Track audits and high-risk monitoring activities in the OnCore clinical trial management system (CTMS)
• Prepare for sponsor visits by collaborating with clinical teams to ensure all necessary activities are completed prior to the visit
• Develop and implement corrective and preventative action plans (CAPA) as needed to address quality issues and ensure compliance
• Contribute to the planning and execution of process improvement pilots aimed at increasing operational efficiency and protocol adherence

Preferred Qualifications

• Experience in leading or supporting process improvement projects or pilots
• Strong interpersonal skills with the ability to collaborate effectively across departments and resolve study-related concerns