UNIV - Research Study Team Program Manager - Hollings Cancer Center

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 t