Apply on Employer Site

MUSC Health · 2 months ago

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

Charleston, SC

Full-time

Onsite

Lead/Staff, Director/Executive

$85K/yr - $157K/yr

5+ years exp

Medical University of South Carolina (MUSC) is seeking a Director of Cancer Clinical Research Audits and Compliance for the Hollings Cancer Center. This senior leadership role will oversee external audit readiness and quality assurance initiatives for cancer research, ensuring compliance with institutional and federal regulations while leading the internal auditing team and collaborating with various stakeholders.

Health CareHospitalMedical

Responsibilities

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

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

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

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

Qualification

Clinical research experienceFederal regulations knowledgeICH Good Clinical PracticeAudit preparationQuality assurance initiativesPerformance coachingCommunication skillsOrganizational skills

Required

A bachelor's degree

Five years relevant program management experience

Prior experience in clinical research

Demonstrated knowledge of the federal code of regulations

Knowledge of ICH Good Clinical Practice guidelines

Excellent communication and organizational skills

Company

MUSC Health

MUSC Health provides health-care services through its patient- and family-centered care, education, research, and various partnerships. It is a sub-organization of Medical University of South Carolina.

Founded in 1824

Charleston, South Carolina, USA

10001+ employees