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

Job Description Summary

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.

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-GEN12

Pay Range

79,600.00 - 111,500.00 - 143,300.000

Scheduled Weekly Hours

40

Work Shift

Job Description

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.

Preferred Knowledge skills and abilities: 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.

Duties:

HCC Statewide Community Site Clinical Research Group (CRG) Administration (25%)

• Assures compliance with the Hollings Cancer Center’s Protocol Review and Monitoring system (PRMS) for scientific review and portfolio oversight and management. As the HCC CRG Administrator, this role will develop the Trial Portfolio Schema (TriPS) that outlines the HCC patient population priorities and cancer trial portfolio activity.
• Collaborate 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
• Collaborate HCC research program members and statewide cancer research stakeholders at MUSC main and beyond in defining the statewide cancer related clinical research priorities.
• Build 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. Facilitate the review of trial opportunities at the CRG meetings and work within the HCC CTO units to communicate CRG trial decisions and develop the trial activation plan.
• Administer the community site CRG meetings and review process, including proper documentation per NCI guidelines. Work with the CRG leaders and AD of Clinical Science to make strategic recommendations for CRG member composition.
• Represent the CRG in biannual HCC PRMS strategic retreats and activities. Work 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.

HCC CTO Community Site Study Program Development (25%)

• Serve as project leader or active participant within University workgroups to support the testing and work guides for HCC community site clinical research operations. Examples include partnering with the University administrative offices to evaluate opportunities to streamline trial activation workflows; Collaborating with Office of Clinical Research (OCR) to align prospective reimbursement analysis and research billing segregation practices within HCC community sites; Supporting OCR Advarra team for establishing new training and policies for leveraging Advarra tools such as OnCore, eReg, and eConsent; Collaborating 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.
• Write and own 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.
• Hire and train new HCC study coordinators to provide dedicated cancer-related trial support either on-site or centrally for HCC community site activities. Assure community site team actively participates in CTO operational meetings and adheres to CTO best practices and policies.
• Support HCC program member faculty and study teams, as needed or requested, as the PI engages and conduct research activities at HCC community sites. This may include deploying HCC resources to provide study visit coordination or data management coverage services, or serving as a subject matter expert to navigate study teams in how to effectively conduct cancer trials at community sites.

HCC Statewide Clinical Research Strategic Leadership (25%)

• Develop and oversee strategic plans to grow the capacity for impactful cancer-related research within HCC community sites. This includes developing a financial sustainability model that can grow dedicated community site oncology resources for active trial screening, recruitment, and compliant study visit and data management.
• Under the guidance of the HCC Community Site Medical Director and the Associate Director of Clinical Science, conduct 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. Responsible for reporting HCC statewide clinical research metrics and activities and professionally escalating 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.  and seek input on program development and metrics.
• 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. Assures that strategic plans align with required policies.

MUSC HCC NCI Community Oncology Research Program (NCORP) Clinical Administration (25%)

• 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.
• Collaborates with the HCC CTO monitoring and auditing teams to conducts site visits to MUSC MU-NCORP affiliate sites 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 Preferred Knowledge skills and abilities: 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.

Additional Job Description

Minimum Requirements: A bachelor's degree and four years relevant program 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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