Clinical Research Financial Practice Manager (Post-Award) - Fully Remote

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 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Be the financial and compliance expert driving the success of impactful clinical research through expert stewardship.

Be You.

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 Arrangement- Fully Remote

All Duke University remote workersmust residein one of the following states or districts: Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Missouri, Montana, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington (State), Washington, DC.

DEPARTMENTAL PREFERENCES

Successful candidates will have previous pre-award AND post-award industry sponsored clinical research administration and financial experience.

MINIMUM QUALIFICATIONS

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 (3) years of relevant grants and contracts experience.

Be Bold.

Skills

• Ability to analyze data and formulate conclusions.
• Ability to learn changing technologies related to grants and contracts management.
• Proficient use of computers; requires solid working knowledge of MS Office Suite (Word, Access, Excel, Power Point).
• Ability to communicate both verbally and in writing with all levels of the organization.
• Ability to manage and prioritize multiple projects/tasks simultaneously.
• Ability to create verbal and written reports.
• Knowledge of federal rules and regulations relating to research grant and/or contract activity
• Knowledge of Duke University policies and procedures relating to grant and contracts activity
• Knowledge of Duke University processes, systems and offices related to and/or involved in grant and contract submission and management.
• Understand and be able to apply federal and university rules to management of effort allocation for individuals compensated whole or in part from federal awards.
• Understand and be able to apply costing rules and regulations to federally funded projects.
• Experience with/Ability to perform required functions in SPS, R3, grants.duke and SES relating to assigned duties.
• Understand financial processes and controls including the reconciliation process
• Understand and be able to assist others in understanding the basic Federal and Duke University rules, regulations and requirements of IRB, IACUC, COI, and IBC.
• Able to escalate issues to higher levels when unable to get cooperation from others.
• Understand and apply the basic concepts of clinical research in the Duke University compliance environment.

Work Performed

Pre-award Job Responsibilities

• 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 task lists 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 task list are complete.

Post-award Job Responsibilities

• 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

• 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.

Choose Duke.

Bring your financial and compliance expertise to a collaborative environment-apply now!