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.OCCUPATIONAL SUMMARY:Provide overall administrative financial management of the Children's Clinical Research Unit (CCRU) by performing and coordinating a variety of financial functions associated with clinical research activities within the Department: including financial reporting and analysis, reconciliation, invoicing, and subsequent monitoring of accounts receivable and tracking accounts payable. Prepare study budgets (internal cost assessments) for each individual study.

Facilitate the negotiation of study budgets and contracts. Produce reports reflecting the profit/loss of individual studies as well as aggregated reports of the overall financial performance of the CCRU, including infrastructure costs and study-specific expenses and revenue. Participate in preparing the annual budget for the CCRU, as required.

WORK PERFORMED:Pre-Award -Site Contracts and Budgets

1. Prepare accurate and realistic internal site budgets (Internal cost assessments) for all new projects by reviewing the protocol and schedule of events, discussing details and logistics with this study team, researching the procedure and lab costs (technical and professional), entering project- specific information into the standard budget template, and applying knowledge of actual costs incurred on previous projects, and other activities related to budget development as needed. Attend study initiation meetings hosted by the Duke Office of Clinical Research (DOCR) for new submissions.
2. Work with appropriate representatives of other Duke departments to determine charges for research procedures and labs. Consider the type of study (i.e. federal versus non-federal) involved and the location where any testing will be performed. Work with DOCR and the appropriate departmental grant manager (if applicable) to assure an appropriate budget for clinical research activity.
3. Enter studies into SPS and request project code.
4. Serve as a central point of contact with sponsors and clinical research organizations (CROs) regarding budgets and contracts (including CDAs) for ongoing and new studies. Interface with PIs and departmental administrators (including the Research Practice Manager and Coordinators) during contract/budget negotiations.
5. Negotiate site budgets with sponsors and CROs based on input and guidance from PIs and study coordinators. Involve PIs as appropriate in negotiations.
6. Initiate and facilitate the internal budget and contract approval process by working directly with sponsor and/or appropriate representatives, ensuring appropriate sign off by the PI and CCRU staff as required, and routing budget to the DOCR and Office of Corporate Research Collaborations (OCRC) for final internal approval via SPS. Adhere to institutional guidelines for industry awards, project extensions, and project code requests.
7. Review and submit information to the Office of Research Administration related to Program content and budgets of contract and grant proposals to ensure compliance with University procedures.
8. Track the status of proposed projects related to budget and contract issues and provide updates to the CCRU leadership, PIs, and staff to support decision-making regarding new studies and resolve funding sources for underfunded projects.

Post Award Accounting / Transaction Analysis

1. Responsible for the creation of the Trial Tracker schedules working closely with the Study Teams to ensure tracking of all patients enrolled and activities performed on subjects has been updated so that revenue earned can be determined monthly. Tracking of all payments received based on the milestone payment schedule or other payment related information specified in the study contract.
2. Work closely with Research Managers of the federal grants to track the enrollment and status of studies as needed.
3. Invoice sponsor as appropriate for negotiated fees and procedures. Monitor accounts receivable and follow up with sponsors as necessary.
4. Provide SOM Finance office with information as needed on all income earned on studies and the status of associated payments.

Prepare monthly reports of the study revenue and update revenue forecasts based on information provided by study coordinators regarding the status of completed benchmarks and report to the CCRU leadership and Division Chiefs and PIs as requested.

Work with other departmental staff to ensure appropriate assignment of faculty and staff effort to site-based research activities in order to meet federal requirements and institutional standards.

Assure that all patient care costs and the reconciliation of charges to R/3 system is performed monthly and serve as a Departmental resource to Clinical Research Coordinators and Grants managers for this process.Ensure invoices are paid promptly and also make sure the CRU fees are transferred each month no more than quarterly. Process checks to ensure that funds are deposited into appropriate fund codes. Outstanding Accounts Receivables should be followed up on a regular basis.

Assist/support coordinators in creating requests for “out of scope” activities based on actual and projected expenses relative to budget and study progress. Facilitate the negotiation of out-of-scope payments with the sponsor.

Coordinate the close-out activity for completed projects and distribute margins in accordance with School of Medicine (SOM) and CCRU procedures, after DOCR final review.

Project / CCRU Reporting and Analysis

1. Track and reconcile all expenditures related to individual projects Prepare and analyze financial statements reflecting revenue and expense for each project on a monthly basis to determine the actual profit/loss of each project.
2. Review the financial status (including P&L and cash flow reports) for each project with PIs and CCRU staff on a monthly basis and make recommendations regarding budget related issues.
3. Prepare monthly accrual entries, as appropriate given standard SOM operating procedures, to match expenditures incurred against revenues earned. Prepare and maintain documentation for the entries, for routine review by SOM Finance and the University Financial Services.
4. Conduct a monthly line item review of project expenses to ensure billing compliance of charges to grants, insurance or discretionary accounts based on budgeted expenditures.
5. Prepare aggregated reports of the CCRU finances (including both project and cost center information) on a monthly basis and review them with CCRU and departmental leadership. Prepare an executive summary of overall financial results that includes any one-time or out of period activity and explains the current run rate and any variances relative to budget.
6. Provide information to the SOM Finance and Administration and/or DOCR to assist in the aggregation of the financial results of all CRUs into an overall report of the finances related to all site-based research.
7. Oversee and facilitate the verification, reconciliation, and correction of technical and professional charges billed to clinical study.

CCRU Operational Budgeting and Analysis

1. Assist with the annual operating budget for CCRU and provide updates throughout the year regarding expense and revenue forecasts.
2. Assist CCRU leadership and Department Business Managers with special financial-related projects as needed.
3. Assist CCRU and departmental leadership in determining appropriate procedures regarding the allocation of CCRU overhead costs and distribution of margin.
4. Interpret departmental policies and procedures, making decisions on specific operating problems and issuing instructions (i.e., patient billing issues, determining the appropriateness of project expenditures based on budgeted expenses, etc.) on behalf of CCRU and departmental leadership in accordance with precedents and policies.
5. Participate in meetings of all CCRU financial managers and provide input regarding institutional standards and systems.
6. Represent the CCRU and department head in meetings with SOM Finance Office, PRMO, DOCR, and other divisions related to budget and contractual issues.
7. Participate in study initiation visits organized by DOCR and communicate and review key contract terms and requirements with the study team at that time.

Other

1. Serve in a leadership role to facilitate communication and interactions within the Department, such as the Senior Grants and Contracts Manager, Grants and Contracts Administrators, Assistant Research Program Managers, and, Research Practice Manager to ensure coordination of information dissemination, activities, and needs are met in terms of clinical research activities. This position also serves as a primary resource to the Grants Administrators in the Department to ensure clinical activities, particularly patient care costs, are handled effectively in both the pre and post-award management.
2. Facilitate communication with Research Managers and Grants administrators to create appropriate budgets, track account status, and complete closeout documents as necessary for the Department of Pediatrics clinical research portfolio.
3. Represent the Department of Pediatrics in meetings related to the FPM position organized by the School of Medicine, DOCR, or Department.
4. Complete other duties as requested.

Preferred Qualifications

• Basic knowledge of, and experience with, accrual accounting concepts and research compliance fundamentals.
• Leadership Skills
• Strongly prefer Duke financial management experience or previous experience in a clinical research setting and knowledge of both industry and government-sponsored clinical research.
• Strong organizational, coordination, and prioritization skills.
• Demonstrated leadership skills in working with various groups and individuals to facilitate efficient processes.
• Excellent customer service and written and oral communication skills.
• Strongly prefer knowledge of Duke University information systems including SPS/ SAP R3.
• Strongly prefer Duke Research Cost Compliance Certification.
• Advanced knowledge of Microsoft Excel.

MINIMUM HIRING REQUIREMENTS:Education/Training: Work requires communications, analytical and organizational skills generally acquired through completion of a bachelor’s degree program. Successful completion of the Research Administration Academy is required. Employees hired into this classification without RAA training will work closely with their manager to schedule and complete the training within 12 months of the start date. The expectation is that the staff member will maintain the requirements for their level. Failing to meet this requirement will be addressed through the performance review. Upon successful completion of expected training, the employee must maintain certification (s) by completing continuing education. Research setting and knowledge of both industry and government sponsored clinical research and related Duke financial experience.Experience/Skills: Work requires 4 years related business or administrative experience to acquire competence in applying general personnel practices, accounting and budgeting principles and coordination of major administrative functions. A master's degree in a business related field may be substituted for 2 years experience. OR ANY OTHER EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE. Prefer 4 to 6 years of experience in clinical research.

Basic knowledge of, and experience with, accrual accounting concepts and research compliance fundamentals. Strongly prefer previous experience in a clinical research setting and knowledge of both industry and government sponsored clinical research.

Minimum Qualifications

Education

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) within first six months of hire is required. Certified Research Administrator preferred.

Experience

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.