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Job Location (Full Address):

601 Elmwood Ave, Rochester, New York, United States of America, 14642

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400840 Ctr Pediatric Biomed Research

Work Shift:

UR - Day (United States of America)

Range:

UR URG 110 H

Compensation Range:

$29.33 - $41.06

Responsibilities:

Serves as the Clinical Trials Research Administrator for the Pediatric Research Office (PRO) in the Center for Children’s Health Research/Department of Pediatrics. Supports all clinical trials and other sponsored projects awarded to faculty in the Department of Pediatrics. Directs and coordinates all aspects of clinical trial lifecycle, with primary responsibility for study start-up, feasibility assessment, budgeting, contract and financial oversight, and sponsor engagement. This position provides guidance and administrative support for all programmatic operations and oversees pre- and post-award management of all sponsored projects. Facilitate proposal preparation and submission process, including extensive budget preparation, and guides faculty and staff to ensure compliance with agency and federal requirements. Oversees accounting activities and reporting, and represents the Department and its faculty in negotiations with agencies and subcontractors. Participates in university-wide policy discussions and has leadership and training responsibilities. Maintains collaborative relationships with Office of Clinical Research, Office of the Dean, Office of Research & Project Administration, Office of Research and Accounting Cost Standards, Purchasing Services and other administrative areas within the University. Demonstrates ICARE* values in each of the major responsibilities.

ESSENTIAL FUNCTIONS

Post award management – Clinical Trials: Examine and monitor financial activity for all clinical trials in the Department of Pediatrics

• Oversee sponsor invoicing and payment tracking, working with Finance to ensure accurate billing, timely collections, and resolution of payment discrepancies.
• Review budgets and study records in OnCore and IORA, ensuring accurate institutional routing, approvals, and alignment with contracts, budgets, and regulatory documentation. Supports timely institutional review and study activation.
• Work closely with Senior Research Coordinators to ensure that PI and coordinator effort is being documented and allocated appropriately and accurately to funded studies
• Review and approve expenditures on sponsored project accounts in accordance with University policy.  Initiate, review and approve salary allocations given proposed effort and program timeline.
• Review account reconciliation monthly.  Identify and resolve errors on accounts in a timely manner. Verify that costs are allowable and allocable and sponsor’s requirements for financial reporting are met.
• Develop and maintain financial models for programs consisting of multiple sponsored project award and make recommendations regarding resource allocation, program no-cost extension requests and planned use for carry-forward funding when available. 
• Work closely with the Office of Clinical Research (OCR) as needed, acting as a liaison.

Post-Award management - Other: Examine and monitor financial activity for all departmental sponsored programs (not focused on clinical trials).

• Review and approve expenditures on sponsored project accounts in accordance with University policy.  Initiate, review and approve salary allocations given proposed effort and program timeline.
• Review account reconciliation monthly.  Identify and resolve errors on accounts in a timely manner. Verify that costs are allowable and allocable and sponsor’s requirements for financial reporting are met.
• Develop and maintain financial models for programs consisting of multiple sponsored project award and make recommendations regarding resource allocation, program no-cost extension requests and planned use for carry-forward funding when available.
• Conduct a financial analysis of all sponsored project accounts, assessing spending reasonability and developing project period projections based on discussions with principal investigators. Review financial position with investigators monthly. 
• Work with principal investigators to appropriately define scope of services for sub-contracts and purchased services.  Monitor sub-contract and PO billing, and evaluate progress on contracted work in comparison to program timeline.

Pre-Award management – Clinical Trials: Provide guidance and assistance in proposal development and pre-award activities for all clinical trials in Pediatrics.  

• Research potential funding opportunities for Department of Pediatrics faculty.  With faculty, determine feasibility of application process and likelihood of award.  Maintain and share proposal, progress/financial reports schedule.
• Provides oversight of all applications for clinical trials including consulting with and assisting principal investigators with proposal preparation, budget development, subcontract and cost sharing issues, proposal sign-off, and other required documentation.
•  Work closely with the Office of Clinical Research (OCR) as needed, acting as a liaison with budget negotiations, etc.
• Represents faculty in negotiations with agencies and subcontractors.
• Directs support staff in updating faculty biographical sketch and other support documentation required for proposal submissions.  Create templates and establish standards for supporting documentation that meet funding agency guidelines.
• Develop proposal budgets based on programmatic needs identified by faculty, University policy and sponsoring agency requirements.  Collaborate with primary award organizations, both nationally and internationally, to develop scope of work requirements and allowable costs.
• Identify gaps in knowledge and designs mini-training programs for leadership faculty related to program development, including identifying sponsors, planning a project, preparing a budget and understanding University and sponsor spending policies.

Pre-Award Management - Other: Provide guidance and assistance in proposal development and pre-award activities, for non-clinical trials.  

• Research potential funding opportunities for Department of Pediatrics faculty.  With faculty, determine feasibility of application process and likelihood of award.  Maintain and share proposal, progress/financial reports schedule.
• Provides oversight of all applications for sponsored funding including consulting with and assisting principal investigators with proposal preparation, budget development, subcontract and cost sharing issues, proposal sign-off, and other required documentation. 
• Represents faculty in negotiations with agencies and subcontractors.
• Directs support staff in updating faculty biographical sketch and other support documentation required for proposal submissions.  Create templates and establish standards for supporting documentation that meet funding agency guidelines.
• Develop proposal budgets based on programmatic needs identified by faculty, University policy and sponsoring agency requirements.  Collaborate with primary award organizations, both nationally and internationally, to develop scope of work requirements and allowable costs.
• Identify gaps in knowledge and designs mini-training programs for leadership faculty related to program development, including identifying sponsors, planning a project, preparing a budget and understanding University and sponsor spending policies.

Coordinate all compliance reporting for the Department and Division’s sponsored programs with an emphasis on clinical trials

• Prepare required financial reports, reconciling to the University’s financial system for review and approval by the Finance Department (ORACS).
• Assist the Principal investigator preparing documents for progress reports, no-cost extension, re-budgeting, carryover, and effort reduction approval to sponsoring agency.
• Serve as primary contact for internal and external audit proceedings or site monitoring visits.
• Prepare the Department/Division’s annual report and certification of effort on sponsored programs, confirming that faculty and staff effort reported to funding agency is consistent with effort expended on the project and amounts paid from the project account.
• Develop procedures to document mandatory and non-mandatory cost-sharing.  Prepare report on collective project costs as needed.
• Assist with the annual research space survey.

Support close-out activities at the end of each project budget period, with an emphasis on clinical trials

• Review account activity and approve final reconciliation of account, adjusting for unresolved issues and outstanding transactions.  Request cost transfers as needed, working closely with accounting staff
• Review and approve final financial statements or reports provided by ORACS.
• Submit required documentation to remove recurring or automated expenses, including salaries, postage, copying, and phone charges.
• Verify all project-end reporting and activity is complete, including final reports, inventions statement, certification of deliverables completed by sub-contract etc. 
• Oversee clinical trials close-out process and transfer of surplus funds.
• Follow-up with ORACS to ensure University’s financial system is updated to prevent future activity on the account.   

Participate in leadership activities to improve organizational capacity and support skill development for staff and faculty.

• Keep abreast of new sponsoring agencies guidelines and evaluate impact of policy changes on existing programs.
• Works in conjunction with principal investigators to develop, revise, and execute strategic plans that appropriately leverage sponsored programs.
• Interprets policy and regulations to other University departments, faculty, and staff.
• Keep current on and inform PI’s and research staff on sponsor rules and requirements.
• Provide annual sponsored program training updates to PI.
• Participates in university-wide committees or teams evaluating business processes to align university and sponsor requirements.
• Give presentations on sponsored-program related activities and issues in a variety of settings including research administrator meetings, divisional and faculty meetings, Research Town Hall meetings, etc.
• Works closely with the Director of the Pediatric Research Office, CFO, and Vice Chairs of Research, helping to set the strategic direction for clinical research in the Department of Pediatrics.

Other duties as assigned

MINIMUM EDUCATION & EXPERIENCE

• Bachelor's degree and 2 years of relevant experience required
• A Master’s degree, equivalent course work, or specialized experience in an appropriate field related to the assignment is desirable.
• Five years relevant experience including at least two years at a managerial level.
• Or equivalent combination of education and experience

KNOWLEDGE, SKILLS AND ABILITIES

• Experience with sponsored program accounting preferred. 
• Strong writing and communication skills preferred. 
• Must demonstrate extensive knowledge of Excel and enterprise accounting systems preferred. 
• Financial reporting experience desired.

LICENSES AND CERTIFICATIONS

• Continuous Learning for Administrators of Sponsored Programs (CLASP) within 1 year required

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