Job Description Summary

Reports up to the CTO Asst. Director for Clinical Activities. Primary responsibilities include the support of timely study activation and achievement of accrual goals to clinical trials within the Disease Focus Groups (DFG) within the respective CTO team. Responsible for providing the HR oversight of the team by directly managing the lead study coordinator, the study coordinators, and data managers. Serves within the CTO management leadership and provide insight and support of CTO strategic initiatives.

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-07

Pay Range

56,210.00 - 80,105.00 - 104,000.000

Scheduled Weekly Hours

40

Work Shift

Job Description

35% Clinical Trial Start-Up: Oversee the clinical trials start-up of all CTO managed clinical trials for the HCC multidisciplinary disease focus groups (DFG) within their assigned team. This position is responsible for managing the adherence of clinical trial start-up tasks to projected timelines. Reviews all new confirmed site interest interventional protocols for feasibility and works with the Resource Allocation and Feasibility Team (RAFT) to provide timely operational trial assessments and develop the final operational plan for new or amended trials. This includes presenting the trial to the ancillary and CTO unit RAFT representatives. When the DFG approves the study for activation, and all In Approval- Step 1 are met, the PM1 will collaborate with the Regulatory PM1 to set the task list targets within the study assigned OnCore task list. This timeline will be the benchmark for addressing time to activation performance. This position should review the study specific timeline and the trial operational plan with the PI to ensure the PI will be available for PRC and IRB meeting timeframes and confirm that the RAFT operational decisions are agreeable to the PI and that these final decisions are documented in the study’s Prioritization, Ancillary, and Decisions for new trials (PADL) form. Once a trial is moved into approval processing, the PM1 will work very closely with the Pre-Award Fiscal Lead and the specific trial pre-award budget specialist to ensure that the Advarra Business Operating Service (BOS) clinical calendars are reviewed to match the current protocol and that any clinically related BOS questions are quickly answered. While the pre-award budget specialist will be responsible for obtaining PI approval of the Coverage Analysis (CA), the PM1 may be needed to help escalate and address PI response delays and help resolve any CA conflicts or questions. As trials move forward, will continue to work with the CTO finance unit via the RAFT meetings the outline of resources required such that budgets can be developed to appropriately support the trial effort. Prior to study activation, the PM1 will be knowledgeable in interpreting CA and will facilitate a review of the final coverage analysis with the budget specialist and the recruiting study coordinator(s) to ensure that the coordinator is competent to discuss what is covered or not covered by the study is accurate and matches the study budget and IRB approved informed consent. This role will oversee that the assigned study coordinator is completing the draft roadmaps and lab processing forms on time and accurately. Will participate in the CTO pending projects meetings and be prepared to present updates and follow through after the meetings to update the DFG leader/PI and help CTO staff members address study-start-up hold-ups/challenges

30% HR Team Management, Training and Mentorship of Clinical Operations Staff: Knowledgeable of local policies and procedures within Hollings CTO, University Compliance, and Institutional Review Board in addition to applicable Code of Federal Regulations and ICH Good Clinical Practice Guidelines. Responsible for recruiting, hiring, supervision, and effective evaluation of all clinical operations study coordination and data management staff within their DFGs. Understanding that selecting a job applicant who best fits the job requirements is paramount, the PM1 is still diligent about filling team vacancies in a timely manner to avoid extended periods of staff coverage. Works with the CTO management and the PCII of their team to ensure proper training of new and existing staff members. Mentors the PCII for developing new skills in clinical operations and team building. May assist the PCII in weekly preparation meetings with clinical staff to ensure that trial start-up, accrual, and study patient management are completed effectively. Listens for process improvement opportunities to train/re-train staff. Will help lead the team’s prioritization of work activities and coach the team in addressing obstacles to high performance. Rounds with physicians, ancillary services, and other external partners to gain feedback of employee performance. Stays abreast of protocol deviations or patient safety events and works closely with the CTO Asst. Directors to identify corrective action plans. Professionally communicates and discusses process improvement opportunities with staff or other stakeholders. If there are individual staff performance concerns, this role will collaborate with the Asst. Director of QAE and the CTO HR/business manager to coach and mentor the staff member and if needed, implement a personal improvement plans per MUSC HR policies. Develops and participates in the formal departmental orientation programs and development and maintenance of a clinical operation employee manual. Works in conjunction with the CTO HR Mgr. to provide updated position descriptions for position postings, conducts candidate interviews and selection. Completes evaluation(s) on the Success Factor’s system based on employee’s actual duties and sets the success criteria for annual rating.Prior to the end of the rating period, the PM1, with the PCII, will conduct staff performance evaluation meetings to provide feedback and help employees grow professionally

25% DFG Administrator and Clinical Research Trial Portfolio Management: Oversee the clinical trials portfolio management of the HCC multidisciplinary disease focus groups (DFG) within their assigned team. This is a multifaceted responsibility that focuses on DFG time to activation, DFG trial accrual rates, and DFG protocol compliance and quality.  Serves as the administrative director of the DFG in partnership with the Cancer Center appointed DFG leader or designee. This involves facilitating the efficiency of each DFG meeting and supporting DFG decision making of DFG trial portfolio management. This means overseeing the compliance of the trial prioritization and resource allocation as directed by the guidelines of the CTO SOPs. Assists with the presentation of trials under consideration by the DFG and facilitates the DFG decision-making of the prioritization for target TTA dates and proposed operational plan. In collaboration with the CTO staff, the PM1 is responsible for relaying the findings from the RAFT to the DFG physicians. Supports the maintenance of the HCC Trial Prioritization Schemas (TriPS) to ensure that pending and active trials are appropriately placed within the correct recruitment patient population. Works with industry and other academic partners in identifying new trial opportunities to fill in trial portfolio gaps. Administers prequalification site visits and communication of site capabilities to potential sponsors. As a DFG administrator, tracks, monitors, and reports to the investigators general trial performance metrics such as time to start-up timeline adherence, accrual goal achievement, and protocol compliance metrics such as acceptable audits, data performance metrics, etc. Works with the regulatory specialist to verify that the DFG agendas are accurate and that meetings maintain a high level of productivity. It is essential that DFG physicians are aware of any delinquencies/challenges to study start-up, accrual, or quality

10%CTO Strategic Planning and Other duties as assigned: Assess employee workload and propose and implement staffing plans to meet trial performance needs. Contribute in CTO Management meetings, HCC Clinical Investigations meetings and other meetings as assigned. Professionally communicate to staff and ancillary group and other related external partners the missions and goals of the HCC CTO to promote buy-in and engagement. Helps oversee that team is following CTO procedures for data and task entries into CTO systems such as the CTMS (OnCore) which populate reporting of trial performance metrics. Establishes corrective action plans with staff should there be issues with performance metric data entry. Thus, a working knowledge of the IT systems and other related policies is required. Assists the CTO Director with special projects and duties to help carry out new initiatives or process improvement pilots. May help with special coverage of CTO activities.

MUSC Minimum Training and Experience Requirements:

A bachelor’s degree andthree yearsrelevant program experience.

Additional Job Description

Minimum Requirements: A bachelor’s degree and three 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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