Grants and Contracts Administrator - Clinical Trials Office

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POSITION SPECIFICS

The Penn State College of Medicine, Clinical Trials Office, in Hershey, PA, is seeking a Grants and Contracts Administrator. 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.

Previous budget development of clinical research preferred. Preference for additional experience with budget negotiations of oncology and non-oncology clinical research.

MINIMUM EDUCATION, WORK EXPERIENCE & REQUIRED CERTIFICATIONS

The Clinical Trials Office (CTO) is entering a pivotal period of growth and transformation. The office is currently supporting the health system's transition to a new electronic medical record (EMR) platform while simultaneously preparing for the replacement of its clinical research management system (CRMS) with a next-generation solution. These changes present a unique opportunity to reshape and improve budget development and financial oversight processes for clinical research.

Qualified candidates for this position should bring prior experience in financial analysis and budget management, ideally within a clinical research or healthcare environment, and apply that expertise to help build the future state of our financial operations. Beyond supporting day-to-day budget development, successful candidates will play a key role in designing and implementing more efficient, standardized, and scalable processes that will strengthen the foundation for how the CTO supports research. These contributions will ensure budgeting functions are accurate and compliant today, while also positioning the CTO to meet the evolving needs of clinical research in the years ahead.

BACKGROUND CHECKS/CLEARANCES

SALARY & BENEFITS

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Penn State provides a competitive benefits package for full-time employees designed to support both personal and professional well-being. In addition to comprehensive medical, dental, and vision coverage, employees enjoy robust retirement plans and substantial paid time off which includes holidays, vacation and sick time. One of the standout benefits is the generous 75% tuition discount, available to employees as well as eligible spouses and children. For more detailed information, please visit our Benefits Page.

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