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Job Description Summary

The HCC Clinical Trials Office is recruiting for a Study Team Program Manager to provide HR oversight of the study team by directly managing the lead study coordinator(s), study coordinators, and data coordinators.

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

57,334.00 - 81,707.00 - 106,080.000

Scheduled Weekly Hours

40

Work Shift

Job Description

Summary:

Reports up to the CTO Asst. Director of Clinical Operations. Primary responsibilities include the support of timely study activation and achievement of accrual goals to clinical trials within the Clinical Research Group (CRG) within the respective CTO team. Serves within the CTO management leadership to provide insight and support of the CTO strategic initiatives.

Responsibilities:

35% Clinical Trial Start-Up: Oversee the clinical trials start-up and amendments of all CTO managed clinical trials for the HCC multidisciplinary clinical research group (CRG) within their assigned team. This position is responsible for managing the adherence of clinical trial start-up tasks to projected timelines. Reviews all trial opportunities and new confirmed site interest 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 CRG investigators approve the study for interest and prioritization, the PM1 will collaborate with the Regulatory managers to prioritize study progression through the start-up stages, across all assigned CRGs. This position should review the study specific start-up 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 and finance unit ensure the recruiting study coordinator(s) are knowledgeable and able to discuss what is covered or not covered by the study per the study budget, fully executed contract 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 CRG 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 CRGs. 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, team building, and CRG management. Meets regularly with the PCII Team Lead Study Coordinator(s) to discuss team needs for training at weekly meetings, additional oversight, and process improvements. Oversee the weekly team preparation meetings to ensure that trial start-up, amendments, accrual, and study patient management, and adequate study visit preparation are completed effectively. 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, clinic staff and other external partners to gain feedback on employee performance. Stays abreast of protocol deviations or patient safety events and works closely with the Quality Assurance and Education Unit and 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(s) of Clinical Operations and the CTO HR/business manager to coach and mentor the staff member and if needed, implement a performance improvement plan per MUSC HR policies. Develops and participates in the formal departmental and clinical operations training materials and meetings as assigned. Works in conjunction with HCC HR to provide updated position descriptions for position postings, conducts candidate interviews and selection. The PM1 is responsible for review and approval of all direct report time, attendance, and leave, per University Policies and HCC CTO SOPs. Completes planning stages and performance evaluation(s) in Ourday based on employee's actual duties. Prior to the end of the rating period, the PM1 will conduct staff performance evaluation meetings to provide feedback to promote employee performance improvement and professional development.

25% CRG Administrator and Clinical Research Trial Portfolio Management: Oversee the clinical trials portfolio management of the HCC multidisciplinary clinical research group (CRG) within their assigned team. This is a multifaceted responsibility that focuses on CRG time to activation, CRG trial accrual rates, and CRG protocol compliance and quality. Serves as the administrative director of the CRG in partnership with the Cancer Center appointed CRG leader or designee. This involves facilitating the efficiency of each CRG meeting and supporting CRG decision making of CRG trial portfolio management. This requires a working knowledge of the diseases and the treatment options within the clinical research group. 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 CRG and facilitates the CRG 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 CRG 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 CRG 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 CRG agendas are accurate and that meetings maintain a high level of productivity. It is essential that CRG 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 to 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. Engages, trains, and follows up with team to ensure the processes and reporting are being implemented sufficiently and accurately. Establish 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.

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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