Job Description SummaryThis is a central research administration position, reporting to the Corporate Budgeting & ClinCard Manager in the Office for Clinical Research (OCR) under the Office for the Vice President for Research (OVPR). This position is responsible for key research finance deliverables for the Office of Clinical Research Industry Sponsor Budgeting and Negotiations program. In collaboration with department/division Grants Administrators, Principal Investigators and study teams, Research Administration and Grants and Contracts Accounting Offices, this position will lead industry sponsored study internal budget development to ensure all clinical research provider fees, MUSC Health, ancillary service provider and personnel costs are covered and the final negotiated budget is financially feasible under this OCR fee for service program. Services will include pre-award and post-award industry sponsored research budget development, analysis, reporting, and communication processes within SPARCRequest or the appropriate system (i.e. Clinical Trials Management System - CTMS).
EntityMedical University of South Carolina (MUSC - Univ)
Worker TypeEmployee
Worker Sub-TypeClassified
Cost CenterCC002113 Office of Clinical Research (OCR)
Pay Rate TypeSalary
Pay GradeUniversity-GEN11
Pay Range66,400.00 - 92,900.00 - 119,500.000
Scheduled Weekly Hours40
Work ShiftJob DescriptionThis is a central research administration position, reporting to the Corporate Budgeting & ClinCard Manager in the Office for Clinical Research (OCR) under the Office for the Vice President for Research (OVPR). This position is responsible for key research finance deliverables for the Office of Clinical Research Industry Sponsor Budgeting and Negotiations program. In collaboration with department/division Grants Administrators, Principal Investigators and study teams, Research Administration and Grants and Contracts Accounting Offices, this position will lead industry sponsored study internal budget development to ensure all clinical research provider fees, MUSC Health, ancillary service provider and personnel costs are covered and the final negotiated budget is financially feasible under this OCR fee for service program. Services will include pre-award and post-award industry sponsored research budget development, analysis, reporting, and communication processes within SPARCRequest or the appropriate system (i.e. Clinical Trials Management System - CTMS).
Job Duties and Responsibilities:30% Internal Clinical Research Budget Development: Analyze clinical research study documents including clinical trial agreements (CTAs/contract), budget, protocol, informed consent, lab and pharmacy manuals, identify services and procedures required to conduct a corporate clinical research study and identify the associated costs to develop an internal clinical research budget that will provide the funding to support the time and effort required to conduct the study.
1. In collaboration with PIs and study teams and utilizing centralized and streamlined OCR intake tools to minimize study team burden, verify study logistics to calculate budget costs. Select services and obtain pricing from SPARCRequest or the appropriate system (i.e. CTMS) service catalog for studies selecting the OCR budget development / sponsor invoicing service.
2. Partner with OCR PRA Managers if MUSC Health services are identified to obtain pricing from Charge Master to support budget development. Verify research record to include protocol and study personnel information, type and source of funding, add the appropriate study assessments and ancillary services (i.e. SCTR, Core Facility), and build study billing calendar/budget template including visits, windows and services to support budget development, sponsor negotiation, invoicing and reporting.
3. Once all costs are captured, analyze the internal budget to identify the breakeven and the potential research contingency funds.
4. Review the internal budget with study teams to ensure that costs are accounted for and adequate research contingency funds are included.
- Work collaboratively and develop effective working relationships with Investigators, key study personnel, departmental finance teams to and Research Administration to accomplish effective budgeting and negotiations.
6. Effectively prioritize tasks, and follow-up to ensure completion of sponsor budgeting activities in a compliant and timely manner.
- Participate in CTMS planning, testing and development to optimize industry sponsored clinical research revenue in alignment with institutional goals.
30% Budget Negotiations with the Sponsor: Translate the research team approved MUSC internal study budget into the sponsor's format for budget negotiations. Analyze clinical trial agreements (CTAs) to ensure that payment terms are aligned with MUSC research team needs and incorporate those requests during budget negotiations (e.g. holdback percentage, data entry timelines).
Ensure that the internal budget analysis, review and approval process is completed during each round of budget negotiations with the sponsor. Provide budget justification documentation to support the budget negotiation process. Once a budget agreement is reached, complete internal routing documentation for contract terms review by ORSP.
1. Work collaboratively and professionally with OCR staff, the Medical University of South Carolina research community, and external research customers such as pharmaceutical companies and Contract Research Organizations (CRO).
2. Work with the department/division business managers to ensure efficiency in the internal routing process.
3. Provide superior customer service to effectively meet the needs of internal and external customers.
4. Ensure that budgeting and negotiation processes are consistent with federal and state regulations and MUSC policies and practices.
5. Upon budget agreement and contract execution, inform sponsor invoicing team and work to ensure budget amounts and terms are effectively communicated for incorporation into study tracker to support sponsor invoicing process.
25% OCR Budgeting Program Continuous Quality Improvement (CQI) initiatives: Optimize the MUSC OCR budeting fee for service program for corporate funded clinical research; identify and develop tools, resources, and training for corporate sponsor budgeting, internal budget development, analysis, communication and reporting.
1. Monitor program performance and analyze operational data to drive Continuous Quality Improvement (CQI) initiatives, including reducing study start-up timelines, enhancing budget negotiation outcomes, and improving payment terms to strengthen invoicing processes and revenue recovery.
2. Develop tools to optimize budget development and negotiations steps and develop / update work instructions to support the process.
3. Serve as an industry sponsored clinical research subject matter expert, develop educational presentations, work on communication templates to support the budget development and negotiation process steps start to finish, website resource development, and budgeting and negotiation methodology supporting documentation.
10% Sponsor Invoicing / Post Award Transition Activities: Transition newly executed clinical trial budgets and Clinical Trial Agreements (CTAs) to invoicing operations by analyzing finalized budget and payment terms and providing feedback and insight to the Invoicing Analyst translating them into study tracking and invoicing workflows within the Clinical Trial Management System (CTMS). Collaborate with invoicing personnel and study teams to ensure accurate interpretation of sponsor payment provisions, invoicing milestones, invoiceable procedures, and pass-through costs. Serve as a resource to the OCR invoicing team by facilitating knowledge transfer, validating study billing requirements, and supporting the timely invoicing, collection, and reconciliation of sponsor payments. Deliver exceptional customer service to internal and external stakeholders while promoting compliance with contractual requirements and institutional processes.
5% Participate in cross-functional, multi-disciplinary OCR work teams based upon institutional and departmental priorities and performs other pre- and post-award, as needed.
Minimum Experience and Training Requirements:Minimum of a bachelor's degree and three years relevant program experience. Employee must have the ability to prioritize and complete required tasks with minimal supervision, interpret and apply regulations and policies, and use resources effectively to complete job tasks
Preferred Experience and Training:
A bachelor's degree in business administration, public administration or the social sciences and 2-5 year
s experience in budget development, contracts and grant administration activities. Experience as a clinical research coordinator, research nurse coordinator, research/sponsored programs accountant, grants administrator, or professional accountant/financial analyst with direct industry sponsored research experience preferred, or an equivalent combination of experience, education and training. Strong project management and organizational skills required. Certification as clinical research professional or equivalent preferred. Knowledge of SPARCRequest, Epic, eIRB, proposal pricing, SmartStream, Darkwing, and research billing highly desirable. Proficient working knowledge of Microsoft office required. Knowledge of grants administration processes, industry sponsored research invoicing, and the clinical research life cycle required.
Physical Requirements: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 outdoorsin all weather and temperature extremes. (Infrequent) Ability to work in confined/cramped spaces. (Infrequent) Ability to perform jobfunctions 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 andshoulders. (Frequent) Ability to reach in all directions. (Frequent) Possess good finger dexterity. (Continuous) Ability to maintain tactilesensory functions. (Continuous) Ability to lift and carry 15 lbs., unassisted. (Infrequent) Ability to lift objects, up to 15 lbs., from floor levelto height of 36 inches, unassisted. (Infrequent) Ability to push/pull objects, up to 15 lbs., unassisted. (Infrequent) Ability to maintain 20/20vision, corrected. (Continuous) Ability to see and recognize objects close at hand. (Frequent) Ability to see and recognize objects at adistance. (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 motorfunctions with frequent fine motor movements. (Frequent) Ability to work in dusty areas. (Infrequent)
Additional Job DescriptionMinimum 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)
