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Job Description Summary
The Hollings Cancer Center Clinical Trials office is recruiting for an Internal Quality Assurance Auditor.
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-GEN09
Pay Range
52,100.00 - 70,300.00 - 88,600.000
Scheduled Weekly Hours
40
Work Shift
Job Description
Summary:
The Internal Quality Assurance Auditor serves as a key member of the Clinical Trials Office (CTO), responsible for implementing research quality assurance measures, conducting internal audits of human subject oncology clinical trials, and supporting compliance with regulatory and institutional standards. This position plays a central role in ensuring protocol adherence, data integrity, and operational excellence across the clinical research portfolio.
Responsibilities:
35% Quality Assurance Internal Auditing.
The auditor conducts comprehensive reviews of national cooperative group trials, Phase II studies, high-risk protocols, and potential FDA registration trials. This includes performing new-employee subject enrollment audits focused on Good Clinical Practice (GCP), IRB SOPs, and CTO best practices. The auditor prepares for NCI National Clinical Trials Network (NCTN) audits, MUSC compliance checks, and sponsor quality control visits by reviewing informed consent documentation, eligibility, treatment administration, adverse events, disease response, and overall data quality. Audit findings are documented using standard templates, entered into the clinical trials management system, and communicated to the QAE Program Manager. This portion of the role requires strong regulatory knowledge, exceptional attention to detail, and the ability to work independently.
35% Quality Assurance Compliance Review.
In this capacity, the auditor verifies subject eligibility, confirms the accuracy of source documentation, and evaluates compliance with oncology protocol requirements. The role requires familiarity with oncology terminology, study coordination workflows, data management processes, and CTO policies. Responsibilities include reviewing research chart organization, patient registration workflows, and documentation practices across systems such as Medidata Rave, TRIAD, electronic patient-reported outcome platforms, and NCI specimen tracking systems. The auditor collaborates closely with clinical teams to resolve compliance issues, maintains strong working relationships across the Hollings Cancer Center and MUSC, and prioritizes tasks to ensure patient safety and data integrity.
20% Quality Assurance Metrics and Monitoring.
The auditor tracks audit activity and high-risk monitoring within the OnCore clinical trial management system and reviews sponsor monitor letters, audit reports, and NCI cooperative group performance metrics. This work includes preparing for sponsor visits, updating follow-up findings in OnCore QA forms, and identifying trends that inform targeted quality assurance initiatives. The auditor collaborates with the QAE Program Manager to support SOP updates, process improvements, and the development of corrective and preventive action plans (CAPA). This portion of the role also involves assisting with the creation and revision of quality assurance guidance documents.
10% supports Quality Assurance Program Development.
The auditor contributes to special projects, new initiatives, and process improvement pilots designed to enhance operational efficiency and protocol adherence. This includes collaborating with ancillary services to resolve study-related concerns, evaluating systems to proactively identify compliance risks, and representing the CTO on MUSC committees or NCTN cooperative group committees. The role requires strong interpersonal skills, professionalism, and the ability to model MUSC's Standards of Professional Behavior.
Additional Job Description
Minimum Requirements: A bachelor's degree and three years of relevant program experience.
Physical Requirements: (Note: The following descriptions are applicable to this section: Continuous - 6-8 hours per shift; Frequent - 2-6 hours per shift; Infrequent - 0-2 hours per shift) Ability to perform job functions in an upright position. (Frequent) Ability to perform job functions in a seated position. (Frequent) Ability to perform job functions while walking/mobile. (Frequent) Ability to work indoors. (Continuous) Ability to work outdoors in all weather and temperature extremes. (Infrequent) Ability to work in confined/cramped spaces. (Infrequent) Ability to perform job functions from kneeling positions. (Infrequent) Ability to squat and perform job functions. (Infrequent) Ability to perform 'pinching' operations. (Infrequent) Ability to fully use both hands/arms. (Frequent) Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent) Ability to reach in all directions. (Frequent) Possess good finger dexterity. (Continuous) Ability to maintain tactile sensory functions. (Continuous) Ability to lift and carry 15 lbs., unassisted. (Infrequent) Ability to lower objects, up to 15 lbs., from height of 36 inches to floor level, unassisted. (Infrequent) Ability to push/pull objects, up to 15 lbs., unassisted. (Infrequent) Ability to maintain 20/40 vision, corrected, in one eye or with both eyes. (Continuous) Ability to see and recognize objects close at hand. (Frequent) Ability to see and recognize objects at a distance. (Frequent) Ability to determine distance/relationship between objects; depth perception. (Frequent) Good peripheral vision capabilities. (Continuous) Ability to maintain hearing acuity, with correction. (Continuous) Ability to perform gross motor functions with frequent fine motor movements. (Frequent)
If you like working with energetic enthusiastic individuals, you will enjoy your career with us!
The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national origin, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need.
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