UNIV - Director of Cancer Clinical Research Audits and Compliance - Hollings Cancer Center

Job Description Summary

The Director of Audits and Compliance is a senior leadership role within the MUSC and the Hollings Cancer Center responsible for oversight of external audit readiness, and strategic quality assurance initiatives for all MUSC cancer research in Charleston, statewide and beyond.

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-09

Pay Range

84,883.00 - 120,967.00 - 157,052.000

Scheduled Weekly Hours

40

Work Shift

Job Description

Summary: 

This role ensures alignment with institutional, federal, and sponsor requirements and contributes to the continuous improvement of clinical research operations. This position will report to the Hollings Cancer Center Associate Director of Clinical Research with an administrative report to the Hollings Cancer Center Clinical Trials Office Administrative Director. The position must have prior experience in clinical research and have demonstrated knowledge of the federal code of regulations and ICH Good Clinical Practice guidelines. 

 

Responsibilities:  

30% External Audit Preparation and Primary Audit Liaison  

Oversees and leads the internal auditing team to ensure external audit readiness. Will manage the CTO internal auditors and serve as the primary liaison for any external audit from an external sponsor, NCI Research base, Theradex, University Compliance, FDA, and other external regulatory entity. Collaborates with MUSC Legal, IRB, and the Clinical Operations Team to ensure audit coordination and institutional alignment. When external audits are announced, this role will support the study Principal Investigator (PI) and lead the CTO internal auditors and all relevant CTO managers to complete audit preparations per the audit checklists and guidance. As external audits are being prepped, this role will oversee the internal audit activities and help in the review of patient and regulatory files to support internal auditing functions and help maximize the audit preparations. Prior to, during and after the audit, this role will serve as the primary communicator with the institutional PI and sponsor and other MUSC stakeholders. After the audit is announced, this role will be responsible for notifying the study team(s) at MUSC or off-site location and collecting and submitting any documents that the auditor requires prior to the submission deadlines. At the conclusion of the audit, this role will organize the exit meeting with auditor, PI, and study team to review preliminary findings and verify with the PI that the findings identified on the final written audit report are accurate. This position is responsible for collating, developing, and submitting audit responses. Leads root cause analysis and ensures implementation of sustainable corrective and preventive actions. This may require working with leadership to engage in root cause analysis and identification of future preventative actions and overseeing the finalizing and communication of all CAPAs. This position must have excellent communication and organizational skills and demonstrate action items are carried out accurately and on time. This role is responsible for proper documentation of all audit submissions and meticulous organization of all audit documents and correspondence.  

30% Reporting and Monitoring of Quality Metrics  

When an audit is completed, the findings will be recorded within the clinical trials management system and appropriately documented per policy or work guide. Reviews HCC institutional metrics related to protocol deviations, data quality and delinquencies rates, query resolution rates, etc. and regularly reports and discusses metrics with program managers and investigators to identify and implement process improvement initiatives to improve quality assurance and data integrity. Utilizing OnCore and other MUSC, HCC CTO, and sponsor systems such as Patient Safety Incidence reporting, Clinical Data Center, NCI’s RAVE, etc. reviews metrics and performance reports and leads corrective action plans to address areas of non-compliance (ineligible patients, deviations, etc), or low-performance (delinquent data and query resolution, inaccurate data and high query rates, ongoing monitoring findings). This position is responsible for the monitoring of audit findings trends and communication of audit trends to the CTO and the HCC Associate Di