This is a central research administration position, reporting to the Hollings Cancer Center Clinical Trials Office Administrative Director. This position provides senior level clinical research expertise for the development, implementation and oversight of the financial, regulatory, and clinical trials reporting for the Hollings Cancer Center Clinical Trials Office. This position functions independently and proactively with strong critical thinking, analytical, and communication skills.
Please review and apply for the position at the following link:
Please contact HCC CTO Administrative Director- Tricia Adrales Bentz at 843-792-9321 or at email@example.com for any questions.
Assistant Director of Administrative Operations at the Hollings Cancer Center Clinical Trials Office
Program Manager II (AH50, Band 8)
Position Type Classified
Position Status Full-Time
Location: Charleston, SC-Main Campus
Pay scale: UNIV-Band 8: $59,161.00 - $84,309.00 - $109,457.00 (min - mid - max)
The Hollings Cancer Center (HCC) Assistant Director of Administrative Operations is a multi-faceted position responsible for management of the regulatory, financial and other administrative functions of the HCC Clinical Trials Office (CTO). This individual will work closely with unit managers and provide supervisory support and mentorship. This position will report to the HCC CTO director and provide financial and administrative metric reporting and participate in strategic planning and program and policy development. The position requires knowledge of the NCI Cancer Center Support Grant (CCSG) and specifically requirements of the Protocol Review and Monitoring System. The position will serve as a liaison to MUSC investigators and external partners and oversee the development of new external partnerships through the grant and other multicenter institutional clinical trials. Included in oversight of research partnerships is the administration of the Minority-Underserved NCI Community Oncology Research Program (NCORP) grant and other external research partnerships. MUSC partnerships include both statewide and national academic and community cancer center collaborations. This individual must be knowledgeable of Food and Drug Administration federal regulations, local regulatory agency policies, and international Good Clinical Practice Guidelines to ensure that the conduct of clinical research activities remain in good standing and research performance excels in quality and efficiency. The position will also need to understand fiscal principals and assist with reporting for the CCSG.
Minimum Experience and Training Requirements:
A bachelor’s degree and four years relevant program experience.
35% Program Management and Development
Oversee the administrative functions of the HCC CTO by supervising and mentoring the administrative unit managers in Regulatory, Finance, PRMS, Quality Assurance, NCI Community Oncology Research Program (NCORP) and the Sponsor-Investigator Support Unit. Work with the unit managers and, as applicable, other University departments to develop policy and procedures for administrative operations and adjust SOPs as new directives or system changes apply. Oversee quality and efficacy of administrative operations. Ensure adherence to federal and local regulations and policies. Oversees the budget negotiations for industrial sponsored trials managed within the CTO and ensures that resources are acquired to meet protocol requirements. Works closely with the HCC CTO Director and HCC Business Manager in overseeing budget operations and development. Works closely with the Protocol Review and Monitoring System to ensure proper organization and maintenance of documents to support compliance to the Cancer Center’s Institutional Data Safety and Monitoring Plan. Work with the HCC’s eleven disease focus groups and clinical leaders in assurance of documentation of the CCSG two-step review process and prioritization of oncology trials. Serve as a liaison to the MUSC oncology research community in helping identify and support new research collaborations. Assist with meeting MUSC faculty in the development of investigator-initiated multi-center studies and FDA Investigational New Drug (IND) applications. Assess risk of new research endeavors and ensure that proper policies are in place to mitigate risk. Oversee the activation process of new clinical trials and track time to activation timelines. Work with MUSC ORSP and CTO-Finance with ensuring proper negotiation, set-up and reporting of trial accounts. Oversee the 5.3 million federal award for NCORP and implement programmatic growth initiatives. Administer the NCORP Steering Committee and conduct ongoing reviews of NCORP trial portfolios.
35% Strategic Planning and Financial Reporting
Collect and analyze key performance metrics and financial reports and propose continuous improvement initiatives and strategic planning. Participate in research leadership meetings and provide input on CTO administrative and finance operations. Monitor compliance to NCI CCSG requirements and help draft key reports to the CTO director. Track and monitor study milestones via University systems and the CTO databases regarding Network and HCC study activities. Responsible for preparation and provision of study specific and unit financial reports to the Cancer Center and departments and monitors the financial feasibility of study accounts. Conduct data quality verifications of the CTO’s clinical trial management system and implement corrective action plans, as needed. Assist with CCSG (DT2, DT3, DT4) reporting in collaboration with the CTO Director. Oversee quality and compliance to the NCI Clinical Trials Reporting Program and Clinical Trials.gov.
15% Quality Assurance and Education
Create and support a quality assurance program for HCC clinical research activities. With minimal supervision, manage and monitor the quality assurance program to include the implementation and continuous improvement initiatives such as developing study specific monitoring plans and standard operating procedures. Collaborate with the IRB, ORSP, and other institutional partners in assuring that HCC CTO policy and procedures meet federal and local regulations. Collaborate with community healthcare centers to build quality research programs which can include assisting with MUSC IRB access, facilitating federal wide assurance amendments, establishing faculty appointments and providing centralized regulatory services. Develop and implement study specific training tools (worksheets, PowerPoint, checklist) to support FDA-mandated Good Clinical Practice training. In support of HCC affiliates, develop and conduct research staff training curriculums aimed at pillars of Good Clinical Practice. Ensures proper training curriculums are also administered to research affiliates of our MU-NCORP grant.
15% Special Projects and Additional Duties
Provide project management of special activities.