Clinical Research Budget Analyst - Clinical Trials Office

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JOB DESCRIPTION AND POSITION REQUIREMENTS:

The Penn State College of Medicine, Clinical Trials Office, in Hershey, PA, is seeking a Clinical Research Budget Analyst. The primary purpose of this position is to conduct activities associated with preparation and negotiation of clinical budget and payment terms for oncology and non-oncology clinical research contract and grant proposals. This position plays an integral part in the study specific designing and building of clinical trial studies into CTMS by converting the study protocol and negotiated budget into a user-friendly interface to ensure billing compliance and proper management of study funds. In addition, the position provides faculty and staff education and training on topics related to clinical research financial management.

• Proposal Preparation and Development:

  • Assist in the budget planning and development process to formulate an initial operating budget for each clinical research project. Evaluate proposals, perform analyses, review budget justifications, and develop alternative scenarios, for clinical research projects, including investigator-initiated proposals funded by the federal government, non-profit, and industry sources.

  • Review all protocols and research related documents, solicit quotes, and develop internal cost estimate. Meet and discuss with research team (investigators, research staff, financial analysts) any potential concerns identified with the conduct of the study. Monitor work performed by others in the budget development process. Coordinate proposal submission and contract negotiation with Office of Research Affairs.

  • Stay abreast of funding guidelines for various funding agencies as mandated by regulations, as well as hospital billing compliance as directed by the Centers for Medicare Services (CMS). Provide input to faculty members and proposal preparation staff on appropriateness of budgeted items to maintain compliance with billing guidelines.

• Negotiation of Agreements:

  • Review highly complex agreements including federal, foreign and industry contracts. Negotiate acceptable contractual terms and conditions in compliance with University policy, and federal and state guidelines for clinical research projects.

  • Negotiate Master Agreement terms, in conjunction with ORA.

  • Consult with ORA, research accounting, risk management, and legal counsel regarding contract and other special terms of agreements.

  • Advise faculty and research staff on negotiated terms of agreements to ensure compliance and adherence to both sponsor and University guidelines, through multiple post award meetings and on-going verbal and written communication.

• Institutional Training and Education:

  • Develop faculty and research staff education programs on specialized research administration topics. Disseminate new knowledge and best practices through various platforms including but not limited to monthly Research Operations and Administrative Rounds, CTO workshops, and other ad hoc groups.

  • Engage in one-on-one meetings with both faculty and research staff from other departments outside the CTO, as needed, to provide more in-depth generalized clinical research training, as well as project-specific guidance.

• Clinical Trial Management System (CTMS) Study Design and Management:

  • Assist with building of clinical trial studies into CTMS by converting the study protocol and negotiated budget into a user-friendly interface to ensure billing compliance and proper management of study funds.

  • Continue user support throughout the life cycle of each trial, including making updates to studies in STAR based on protocol and/or budget analysis.

  • Collaborate with patient financial services, study teams, and post-award financial analysts to resolve research billing issues.

• Departmental Training, Education and Supervision:

  • Mentor CTO lower-level Grants and Contract Administrator staff including directing work assignments and teaching best practices for budgeting and negotiating of oncology and non-oncology clinical research.

  • Provide subject matter expertise to fellow CTO colleagues involved in all pre-award and post-award processes.

Hybrid and Remote work arrangements are available.

This position will be filled at an Advanced, Senior, or Principal Professional depending on the candidate's education and experience. This position requires Bachelor's Degree and 3+ years of relevant experience or an equivalent combination of education and experience. Additional education and/or experience required for higher level positions. Previous budget development of clinical research preferred. Preference for additional experience with budget negotiations of oncology and non-oncology clinical research.

The following clearances must be successfully completed for this position:

• Pennsylvania State Police Criminal Background Check

• Pennsylvania Child Abuse History

• Federal Bureau of Investigation (FBI) Criminal Background Check

The Pennsylvania State University is committed to and accountable for advancing diversity, equity, and inclusion inall ofits forms.We embrace individual uniqueness, foster a culture of inclusive excellence that supports both broad and specific diversity initiatives, leverage the educational and institutional benefits of diversity, and engage all individuals to help them thrive. We value inclusive excellence as a core strength and an essential element of our public service mission.

The salary range for this position, including all possible grades is:

Salary Structure - additional information on Penn State's job and salary structure.

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