UNIV - Assistant Director of Community Site Research - Hollings Cancer Center

Medical University of South Carolina•Charleston, SC

1d•Hybrid

About The Position

The Assistant Director of Hollings Cancer Center Community Site Research provides strategic leadership for the statewide cancer-related trial portfolio that recruits from oncology clinics beyond the HCC Research Center at Main Campus. This role will report to the HCC Community Site Medical Director and the Associate Director of Clinical Science, while operationally reporting up to the HCC Clinical Trials Office (CTO) Administrative Director. As part of National Cancer Institute (NCI) Designated Cancer Center requirements for Protocol Review Monitoring System (PRMS), HCC is required to rigorously review and oversee the progress of all oncology clinical trials. This PMII role will serve a critical role in the program development of the HCC Community Site Clinical Research Group (CRG). The CRG is a component of the HCC PRMS and is responsible for the first stage scientific review and feasibility prioritization. Additionally, this individual is responsible for professional collaboration with HCC CRG faculty leaders across 10+ MUSC departments/divisions, community physician investigators and staff at all statewide oncology practice locations, and the University and MUHA enterprise leaders. Overall, this position will support the HCC in the identification and implementation of strategic initiatives to grow the HCC community sites pipeline of cancer studies, increase statewide cancer trial accrual, and enhance efficiency and quality of statewide cancer trial operations. Remote/Hybrid may be available after an orientation period.

Requirements

A bachelor's degree and four years relevant program experience.

Nice To Haves

Must be knowledgeable of work guides and procedures and ensure that the monitoring team is accurately reviewing competencies against current policies, work guides and best practices.
Demonstrates knowledge of NCI Cancer Center Support Grant (CCSG) expectations, University Research Governance, Institutional Review Board, Office of Research Sponsored Programs policies, work processes and reporting requirements.

Responsibilities

Assures compliance with the Hollings Cancer Center’s Protocol Review and Monitoring system (PRMS) for scientific review and portfolio oversight and management.
Develops the Trial Portfolio Schema (TriPS) that outlines the HCC patient population priorities and cancer trial portfolio activity.
Collaborates with the HCC Community Outreach and Engagement (COE) and specifically the Assistant Director, Data Science and Analytics to support the PRMS CRG leaders in understanding the volume and characteristics of the statewide patient population.
Collaborates with HCC research program members and statewide cancer research stakeholders at MUSC main and beyond in defining the statewide cancer related clinical research priorities.
Builds meaningful collaboration and communication systems with HCC CRG leaders and investigators, community site oncology practice investigators, and University and research sponsor stakeholders to identify cancer-related trial opportunities for activation at community sites.
Facilitates the review of trial opportunities at the CRG meetings and works within the HCC CTO units to communicate CRG trial decisions and develop the trial activation plan.
Administers the community site CRG meetings and review process, including proper documentation per NCI guidelines.
Works with the CRG leaders and AD of Clinical Science to make strategic recommendations for CRG member composition.
Represents the CRG in biannual HCC PRMS strategic retreats and activities.
Works with the HCC Protocol Review Committee (PRC) Chairs and Administrator to support strategic initiatives that lead to efficient PRMS reviews and statewide cancer trial portfolio growth and progress.
Participates in the PRC Accrual Review subcommittee and supports timely and accurate metric reporting of all statewide cancer research activities.
Serves as project leader or active participant within University workgroups to support the testing and work guides for HCC community site clinical research operations.
Collaborates with Office of Clinical Research (OCR) to align prospective reimbursement analysis and research billing segregation practices within HCC community sites.
Supports OCR Advarra team for establishing new training and policies for leveraging Advarra tools such as OnCore, eReg, and eConsent.
Collaborates with clinical service lines to support high quality and timely data source documentation for clinical evaluations such as RECIST or central imaging and pathology study submission requirements.
Writes and owns new HCC CTO standard operating procedures (SOP) that align community site cancer trial operations to local and federal regulations and help enhance activity standardization and quality.
Hires and trains new HCC study coordinators to provide dedicated cancer-related trial support either on-site or centrally for HCC community site activities.
Assures community site team actively participates in CTO operational meetings and adheres to CTO best practices and policies.
Supports HCC program member faculty and study teams, as needed or requested, as the PI engages and conduct research activities at HCC community sites.
Develops and oversees strategic plans to grow the capacity for impactful cancer-related research within HCC community sites.
Conducts an annual needs assessment and round with University leadership, HCC program members, and other stakeholders to determine opportunities for process improvement.
Meets regularly with HCC leadership through the Clinical Research Executive Committee.
Reports HCC statewide clinical research metrics and activities and professionally escalates concerns or operational barriers as needed.
Communicates HCC community site research program services and program policies to stakeholders.
Participates in HCC CTO leadership meetings and serves on HCC CTO committees such as the CTO SOP committee or education committee.
Participates in the MUSC NCORP Executive committee and provides advisement on trial feasibility and trial portfolios within the HCC community sites.
Responsible for collecting timely trial feasibility information among NCORP affiliate sites, and assessing community site interest.
Conducts site visits to MUSC MU-NCORP affiliate sites, including on-site monitoring and quality support visits, to assess operational practices, provide real-time feedback, and promote consistent application of protocols, SOPs, and quality standards across participating sites.
Monitors NCI Research base performance reports and other CTO dashboards to track high-risk events (e.g. decline in data submissions, increases in queries, sponsor complaints, new investigators, new research sites, etc.) and initiate timely quality reviews to assess protocol and regulation compliance.
Monitors NCORP trial accrual and works with the NCORP mPIs to develop initiatives for NCORP affiliates in meeting of exceeding accrual targets.