Apply on Employer Site

MUSC Health · 3 months ago

UNIV - Research Study Team Program Manager - Hollings Cancer Center

Charleston, SC

Full-time

Onsite

Mid Level

$57K/yr - $106K/yr

3+ years exp

Medical University of South Carolina (MUSC Health) is seeking a Research Study Team Program Manager for the Hollings Cancer Center. The role involves providing HR oversight of the study team, managing clinical trial start-ups, and ensuring adherence to timelines and compliance within the clinical research group.

Health CareHospitalMedical

Responsibilities

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

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

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

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

Qualification

Clinical Trial ManagementHR ManagementRegulatory ComplianceClinical Research KnowledgeBudget ManagementProcess ImprovementTeam LeadershipMentorshipCommunication SkillsProblem Solving

Required

A bachelor's degree and three years relevant program experience

Company

MUSC Health

MUSC Health provides health-care services through its patient- and family-centered care, education, research, and various partnerships. It is a sub-organization of Medical University of South Carolina.

Founded in 1824

Charleston, South Carolina, USA

10001+ employees