UNIV - Director of Cancer Clinical Research Audits and Compliance - Hollings Cancer Center bei Medical University of South Carolina (MUSC)

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 Director of Clinical Science. This position will prepare presentations and reports to present quality information to HCC stakeholders. Participation in the HCC Clinical Research Executive Committee (CREC) as a member will be required, and quality assurance updates will be professionally shared with HCC leadership. 

  

30% Quality Assurance Strategic Planning  

Supports innovation in quality assurance practices and contributes to strategic planning initiatives across the Cancer Center. Administers the Quality Assurance Committee which is responsible for reviewing audit and monitoring findings to identify trends. This committee will serve as the core group to maintain all clinical research SOPs and publication/dissemination to clinical research teams. As audits result in corrective action plans, the quality committee will assess the SOPs and guidance documents for any revisions to support the implementation of the corrective action. The committee will also set metrics to assess the quality assurance impact measurement of corrective actions. Should a quality measure not show improvement or face barriers to implement a corrective action plan initiative, this role will promptly discuss with cancer center leadership to identify solutions. The role will identify and communicate areas of need, potential growth, and assess emerging quality assurance trends and meets with the HCC Associate Director of Clinical Science and Administrative Director of the Clinical Trials Office on a routine basis to assess and propose thoughtful analysis and recommend options for the strategic growth and maintenance of a high-quality CTO operation.   

10% Unit Management and Additional duties   

Serves as the supervisor of the CTO internal auditing team and is responsible for the human resources responsibilities for posting vacant or new positions within the auditing unit. Will provide performance coaching to unit staff and adhere to all supervisory roles and responsibilities. From time to time, grant renewals or new funding opportunities may arise that will require assistance with pulling out various metrics and providing special ad hoc reports. From time to time, the Cancer Center, Institution and/or partnering academic cancer center or professional organization may have a may have committees and continuous improvement or strategic planning task forces, as assigned that will require representation from the HCC CTO. 

Additional Job Description

Minimum Requirements: A bachelor's degree and five years relevant program management 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 lift objects, up to 15 lbs., from floor level to height of 36 inches, 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 match or discriminate between colors. (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 hear and/or understand whispered conversations at a distance of 3 feet. (Frequent) Ability to perform gross motor functions with frequent fine motor movements. (Frequent) Ability to work in dusty areas. (Infrequent)

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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