School of Medicine
Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.
Occupational Summary
This position will be located within the School of Medicine Shared Research Administration Resource Group and will play an active role in working with specifically identified departments to manage their portfolio of grants and contracts.
Pre-award activities include support for clinical research, including trials, for PI initiated and Sponsor initiated studies, for multiple clinical research programs.
Ensure all applications and contracts meet sponsor/agency and university guidelines adhering to the necessary internal and external deadlines.
Post-award activities include detailed reconciliation of assigned project budgets, preparing complex budget reports, preparing adjustments and corrections in assigned project budgets for further review and approval in order to meet project goals and federal requirements.
You will effectively manage assigned projects and financial project portfolios using independent judgment and discretion to make decisions that impact the compliance and successful completion of the clinical research studies.
You will build and maintain close collaborative working relationships with the Principal Investigators (PIs), key study personnel and colleagues throughout Duke to effectively manage the financial activities of research studies.
This position is responsible for a highly complex portfolio using discretion and independent judgment to make decisions that impact the compliance and successful completion of grants and contract objectives. This position is expected to manage a mid- sized unit (school, department, division, institute, or center) with a well defined portfolio.
This position functions as a manager and/or facilitator of large projects, such as grants and contracts that span across multiple disciplines and faculty using knowledge of grants and contract management rules and regulations, technical expertise, and analytical skills.
Work Performed
Pre-award Job Responsibilities (30%)
Develop budgets and budget justification, in collaboration with PI/Research Team and any necessary supporting departments, including proofing the budget for inconsistencies, ensuring accuracy and compliance with study protocol.
Arrange and participate as a leading role in budget development, utilizing the clinical research management system OnCore.
Implement, where appropriate, the One-Duke budgeting process in collaboration with central offices (e.g. Duke Office of Clinical Research and School of Medicine Finance).
Participate in DOCR study initiation and One-Duke budget meetings utilizing the One-Duke budget template as appropriate.
Prepare and submit grants and contracts through pre-award process utilizing both Sponsor and Duke regulations. Follow through to submission to Sponsor.
Submit contracts through the SPS system for approval. Ensure receipt of sponsor signatures on final agreement.
Advise the faculty/PI on administrative requirements in preparing proposal and contract submissions.
Assist faculty/PI and study team with development of internal cost assessment or equivalent such as the One-Duke budget template..
Review informed consent to ensure it is consistent with the budget and financial terms outlined in the agreement.
Obtain management approval on external and internal budgets before sending to the sponsor for review.
Monitor compliance with agency and University regulations regarding submission; verify all financial information, including the application of the appropriate overhead rate for the project.
Negotiate budget and payment terms to completion with the approval from the Principal Investigator, research team and Unit leadership.
Ensure OnCore and other Duke systems contain the final and accurate budget and payment details.
Ensure that all role appropriate OnCore tasks and tasklists are completed and follow project through to institutional final approval.
Interpret contractual payment terms and prepare final contract and associated budget and documents for initial invoice and ensuring all appropriate finance related OnCore tasks and tasklist are complete.
Post-award Job Responsibilities (50%)
Read and develop a full understanding of the terms and conditions of the executed budget and payment schedule in order to set-up and effectively manage study finances.
Manage the patient reimbursement process in a timely manner and act as Clincard Site Administrator where necessary.
Monitor and determine appropriate charging of all expenses (including the FAM reconciliation process) and ensure patient care expenses are compliant.
Ensure processes are in place within the unit for proper handling of sponsor checks for deposit and recording in the appropriate fund codes. This must be handled in accordance with the institutions check handling process.
Use appropriate Duke systems, such as OnCore, to promptly invoice, collect, deposit and record funds to the appropriate fund code according to the executed study budget and payment schedule for study start-up, ongoing per patient revenue, and all other earned invoice able payments. Follow up as needed to ensure invoices are paid promptly.
Manage overdrafts and communicate with Unit leadership overdraft management plans on a monthly basis.
Ensure that the Clinical Research Unit (CRU) Startups and Management Fees are managed according to Unit and Institutional Policies. Close-out studies in a timely manner in compliance with School of Medicine (SOM) policy and the requirements of the funding agency, as applicable. Transfer any residuals in accordance with Unit and School of Medicine (SOM) policy.
Work closely with the study team to manage effort and make adjustments as needed to ensure that funding sources are properly aligned with the effort of faculty and study staff, while maintaining compliance with funding agencies policies.
Monitor proposal and contract status and advise faculty/PI on requirements and deadlines associated with research protection protocols.
Reconcile monthly budget reports and inform faculty/PI and/or supervisor of potential corrections/adjustments made.
Monitor accounts receivable and aged debt. Prepare OnCore invoices and/or AR journal voucher(s) as necessary.
Perform monthly OnCore reports to assess items available for invoicing and track participant and study activities.
Monitor compliance with agency and University regulations regarding reporting.
Maintain financial records per the institutional documents retention guidelines.
Establish and/or interpret departmental policies and procedures, making decisions on specific operating problems and issuing instructions on behalf of the unit.
Perform all portfolio management responsibilities using tools available to monitor compliance with Duke policies.
Produce monthly reports and fiscal forecasts for the study team. These reports should have sufficient detail for study teams to make informed decisions about their research portfolio, Hub accounts and other necessary accounts.
Management Responsibilities (20%)
Develop project management plan for review by the faculty/PI or senior level grants administrator.
Serve as primary liaison with sponsors, study personnel and PIs. Collaborate, and communicate with other study personnel as required. Communicate concerns clearly in a professional manner. Respond timely to emails, phone calls and questions. Refer more complex questions and escalate issues to others as appropriate.
Apply sponsor and university rules to appropriately manage effort for individuals compensated, in whole or in part, from sponsored awards.
Submit reports to the Divisional Administrator/Business Manager/Director/Leadership when requested.
Provide oversight of portfolio in OnCore, maintaining correct reporting of unit protocols and ensuring research administration related data entered into OnCore is accurate.
Required Qualifications at this Level
Education/Training:
Work requires communications, analytical and organizational skills generally acquired through completion of a bachelor's degree program. Research or grants education and/or certification is preferred.
Successful completion of Financial Services Introduction to R3, Introduction to Duke GL, Introduction to Accounting, Sponsored Research Reporting, Research Administration at Duke (online), Basic Compliance (online), Duke Human Research Training (online), Budget Development and Negotiation Training, and Industry Funded Clinical Research—Process for Contracts within first six months of hire is required.
Successful completion of the Research Administration Academy (RAA) and Advanced Grants Management (AGM) is expected. Employees hired into this classification without RAA training will work closely with their manager to schedule and complete the training within 12 months of start date and AGM within 18 months. The expectation is that the staff member will maintain the requirements for their level. Failing to meet these requirements will be addressed through the performance review process.
Upon successful completion of expected training, the employee must maintain certification(s) by completing continuing education requirements.
Experience:
Work generally requires three years of relevant grants and contracts experience.
Successful candidates will have previous clinical research administration experience and/or pre-award AND post-award administrative and financial experience.
Skills:
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Work requires communications, analytical and organizational skills requirements. generally acquired through completion of a bachelor's degree program. Research or grants education and/or certification is preferred. Successful completion of the Research Administration Academy (RAA) and Advanced Grants Management is required. Employees hired into this classification without the expected credentials will work closely with their manager to schedule and successfully complete all training (12 months to complete RAA and an additional 6 months to complete AGM). Successful completion of all expected training will be an annual performance goal until complete. Upon completion of expected training, the employee must maintain Research Administration Academy (RAA) certification and Advanced Grants Management (AGM) certification by completing continuing education Successful completion of Financial Services Introduction to R3, Introduction to Duke GL, Introduction to Accounting, Sponsored Research Reporting, Research Administration at Duke (on-line), Basic Compliance (on-line) withinfirst six months of hire is required. Certified Research Administrator preferred.
Work generally requires three years of relevant grants and contracts experience.
Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
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