UNIV - Quality Assurance Auditor and Education Specialist - Hollings Cancer Center

Job Description Summary

The Internal Quality Assurance Auditor and Education Specialist is an integral part of the Clinical Trials Office (CTO). This role focuses on implementing research quality assurance measures and overseeing the education, orientation, and continuous professional development of research staff involved in human subject oncology clinical research. Additionally, this position ensures compliance
with regulatory standards and fosters excellence in trial execution.

Entity

Medical University of South Carolina (MUSC - Univ)

Worker Type

Employee

Worker Sub-Type​

Classified

Cost Center

CC001332 HCC CTO Administration

Pay Rate Type

Salary

Pay Grade

University-06

Pay Range

46,655.00 - 66,488.00 - 86,321.000

Scheduled Weekly Hours

40

Work Shift

Job Description

35% Quality Assurance Internal Auditor-Responsible for conducting various human subject clinical trial audits within the CTO to ensure protocol compliance. This role includes auditing national cooperative group clinicaltrials, Phase II trials, high-risk trials, and potential FDA registration trials. Key Responsibilities - Conduct new employee subject enrollment audits focusing on Good Clinical Practice (GCP), IRB SOPs, and CTO best practices for national studies and other non-monitored trials. Perform internal reviews in preparation for NCI National Clinical Trials Network (NCTN) audits, MUSC compliance checks, and or sponsor quality control visits for the following content areas, informed consent, eligibility, treatment, adverse events,disease response, and data quality. Complete audit reports using standard report templates in a timely and accurate manner. Communicates findings to QAE Program Managerand enters findings within the clinical trials management system. Qualifications - 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, and effective verbal and written communication skills.

35% Quality Assurance Education Specialist-Collaborates 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. This role focuses on patient eligibility and safety, data integrity, and oncology protocol compliance within the Clinical Operations unit. Key Responsibilities - Ensure patient eligibility and safety, data integrity and oncology protocol compliance. Demonstrate knowledge of clinical oncology terminology, study coordination, data management roles, HCC internal workflows, and procedures & policies. Confirm subject eligibility for enrollment and complete source documentation verification for selected case report form fields to ensure data integrity. 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. Utilize approved QAE training documents for staff development. Establish and maintain effective working relationships with HCC and MUSC colleagues. Proactively plan, prioritize, and manage responsibilities to ensure patient safety, protocol compliance and data integrity. Qualifications - In-depth knowledge of federal, state, institutional, IRB, and CTO regulations and policies. Strong understanding of FDA, GCP, and ICH regulations. Proven ability to train and educate staff on complex research, regulatory, and procedural topics.

20% Quality Assurance Metrics- Responsible for tracking audits and high-risk monitoring activities in the OnCore clinical trial management system (CTMS) and leveraging tools suchas t he CTO Clinical Data Center, NCI RAVE metrics, performance reports, and subject metrics to develop educational tools and training sessions to address areas of non-compliance and create educational materials and training sessions to address these gaps. Key Responsibilities - Track sponsor monitor letters, audit reports, and NCI cooperative group performance reports within OnCore CTMS. Prepare for sponsor visits by collaborating with clinical teams to ensure all necessary activities are completed prior to the visit. Review follow-up monitor visit letters and update findings within OnCore QA forms. Review follow up monitor visit letters and updates findings within OnCore CTMS. Communicate identified trends and findings with the QAE PM to help develop targeted quality assurance initiatives. T