UNIV-Quality Assurance Auditor - Hollings Cancer Center

Medical University of South Carolina•Charleston, SC

5d•$52,100 - $88,600•Onsite

About The Position

The Hollings Cancer Center Clinical Trials office is recruiting for an Internal Quality Assurance Auditor. 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.

Requirements

A bachelor's degree and three years of relevant program experience.
Strong regulatory knowledge.
Exceptional attention to detail.
Ability to work independently.
Familiarity with oncology terminology, study coordination workflows, data management processes, and CTO policies.
Strong interpersonal skills.
Professionalism.
Ability to model MUSC’s Standards of Professional Behavior.

Responsibilities

Conducts comprehensive reviews of national cooperative group trials, Phase II studies, high‑risk protocols, and potential FDA registration trials.
Performs new‑employee subject enrollment audits focused on Good Clinical Practice (GCP), IRB SOPs, and CTO best practices.
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.
Documents audit findings using standard templates, enters them into the clinical trials management system, and communicates them to the QAE Program Manager.
Verifies subject eligibility, confirms the accuracy of source documentation, and evaluates compliance with oncology protocol requirements.
Reviews 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.
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.
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.
Prepares for sponsor visits, updates follow‑up findings in OnCore QA forms, and identifies trends that inform targeted quality assurance initiatives.
Collaborates with the QAE Program Manager to support SOP updates, process improvements, and the development of corrective and preventive action plans (CAPA).
Assists with the creation and revision of quality assurance guidance documents.
Contributes to special projects, new initiatives, and process improvement pilots designed to enhance operational efficiency and protocol adherence.
Collaborates with ancillary services to resolve study‑related concerns, evaluates systems to proactively identify compliance risks, and represents the CTO on MUSC committees or NCTN cooperative group committees.