Clinical Trials Budget Specialist

Req #: 237827Department: DEPARTMENT OF MEDICINE: HEMATOLOGY AND ONCOLOGYAppointing Department Web Address: https://hemonc.uw.edu/Posting Date: 08/19/2024Closing Info:

Closes On 08/26/2024Salary: $5,810 - $8,573 per monthLimited Recruitment: Open to Department employees onlyShift: First ShiftNotes:

As a UW employee, you will enjoy generous benefits and work/life programs. For a complete description of our benefits for this position, please visit our website, click here. (https://hr.uw.edu/benefits/wp-content/uploads/sites/3/2018/02/benefits-professional-staff-librarians-academic-staff-20230701a11y.pdf )As a UW employee, you have a unique opportunity to change lives on our campuses, in our state and around the world. UW employees offer their boundless energy, creative problem-solving skills, and dedication to build stronger minds and a healthier world.UW faculty and staff also enjoy outstanding benefits, professional growth opportunities and unique resources in an environment noted for diversity, intellectual excitement, artistic pursuits, and natural beauty.The Department of Hematology and Oncology has an outstanding opportunity for a Clinical Trials Budget Specialist to join their team. POSITION PURPOSE The Central Admin Clinical Trials Budget Specialist is responsible for clinical research budgeting and revenue cycle strategy, development and oversight across all Division Teams within the Division of Hematology and Oncology. Specifically, this position oversees and negotiates optimal pricing and payment terms for investigator initiated and industry sponsored clinical trials, ensuring regulatory compliance and fiscal accountability. This position is also responsible to lead revenue recovery, assisting and training teams in revenue recovery. At any given time, up to 25 research projects may be in various stages of development and/or negotiation. This position requires in-depth knowledge and experience in clinical research coordination, revenue cycle development, budgeting, compliance, and regulations. This position reports to the Clinical Research Budget Manager and works closely with research faculty and staff in the Division of Hematology and Oncology.POSITION COMPLEXITIES Hematology and Oncology is a Division within the Department of Medicine. The Division has as its primary mission, to improve cancer care by moving discoveries made in the laboratory to a clinical setting and finding new and innovative ways to use existing therapies. Our vision is to be national leaders in oncology translational medicine.The Division of Hematology and Oncology is primarily located on the Fred Hutch Cancer Center campus, but also has faculty and staff located at University of Washington (UW) Medical Center, Harborview Medical Center, the VA Puget Sound Health Care System, and South Lake Union. As such, this position is required to continuously integrate information from multiple sources to ensure that our clinical research proposals meet the requirements of the University, external agencies, institutions and industry. This position interacts closely with clinical and administrative departments and regulatory committees, providing information and coordinating efforts across multiple process partners, including UWMC, FHCC and HMC.POSITION DIMESIONS AND IMPACT TO THE UNIVERSITY This position is key to the success of the Division's research programs, promoting timely and efficient study start-up while ensuring the program’s clinical research studies are compliant and financially sound. This will require a strong partnership with faculty and staff both within and external to the program.DUTIES AND RESPONSIBILITIES Clinical Trial Budget Development, Revenue Cycle, and Financial Risk Management - 50%

Understand and exercise independent judgment in interpreting complex oncology clinical trial protocols to develop study-specific budgets that account for all procedural and labor costs.

Perform comprehensive and independent review of all documents related to the research study funding, including study budget, protocol, consent form, contract, and other supporting documentation.

In collaboration with Principal Investigators, identify and differentiate between research-specific procedures and standard of care.

Using established systems and committees, seek appropriate prices quotes from University of Washington, Fred Hutch Cancer Center, and other partner institution service departments.

Independently negotiate successful clinical trial budgets and payment terms with study sponsors.

Understand and interpret all institutional, state, and federal policies related to clinical research budgeting and billing; act as Division expert on such polices.

Participate in Program research meetings and budgeting/start up committee meetings as needed.

Develop tools and metrics with the goal of increasing study budgeting process efficiencies and streamlining operations.

Coordinate with disease program research staff to ensure each study’s consent form delineates research care and standard of care.

Coordinate with UW and FHCC offices involved in the review and negotiation of clinical trial budgets and contracts, including UW Clinical Research Budget and Billing office, the UW Office of Sponsored Programs, and the FHCC Research Implementation Office.

Advise teams and faculty on the financial strength of contracts, including recommending not activating a study if full cost recovery is not achievable through negotiation.

Review and approve budgets prior to and after negotiation from centralized start up services.Post Award Revenue Recovery - 50%

Perform comprehensive and independent review of patient activity, and in comparison to the Clinical Trial Agreement, perform complex financial reconciliations to ensure full revenue recovery.

Identify invoiceable items in contracts and ensure regular invoicing and accounts receivable aging follow up.

Use CTMS system, ONCORE, for financial reconciliation of studies that are operational in that system.

Independently troubleshoot payment issues with sponsors in a timely manner.

Identify and assist faculty to mitigate budget deficits, including communication with sponsor for amendments.

Interpret and analyze budgets both during active period and post closure, to provide feedback to budget building teams on areas of concern and strength.

Provide training to fiscal staff on full revenue recovery, how to invoice and assist in development of staff to manage post award revenue

Collaborate with faculty, research and fiscal staff in the development of clinical research revenue cycle policies. Monitor and assess program compliance around clinical trial budget development, identifying opportunities for improvement and implementing changes to stabilize and strengthen compliance.

Participate in Program and Institutional meetings as needed.

Other duties/projects as assigned.Lead Responsibilities

Serve as Program expert on clinical trial budgeting and revenue cycle development, policies and complianceMINIMUM REQUIREMENTS Bachelor's Degree in Business, Science or health-related field

Minimum three years’ experience with clinical research budget development, clinical research coordination, or related research or healthcare experience.Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration. ADDITIONAL REQUIREMENTS Ability to work effectively and efficiently in a group environment

Exceptional organizational and customer service skills

Strong written and oral presentation skills

Ability to communicate effectively with all levels of faculty, management and clinical research staff

Ability to convey complex policy, financial and scientific/technical information in a manner that is understandable to a wide audience

Ability to teach and mentor others in group settings, in one-on-one sessions, and remotely

Ability to prioritize and organize work independently

Demonstrated skill in using Microsoft ExcelDESIRED QUALIFICATIONS Experience in an academic medical center

Experience negotiating clinical trial budget and payment terms

Experience as a research study coordinator

Experience in oncology clinical research

Familiarity with interpreting regulatory and contractual documents, identifying and resolving ambiguities, negotiating pricing and payment terms, and interpreting complex implications of research protocols.

Knowledge of the Medicare Clinical Trials Policy and other federal, state and institutional clinical research regulations

Experience with using International Classification of Diseases, 9th Revision (ICD-9), Current Procedural Terminology (CPT), and Healthcare Common Procedure Coding System (HCPCS) billing codes in a clinical research environment

Strong working knowledge Microsoft Office SuiteCONDITITONS OF EMPLOYMENT Fast-paced office environment with a high volume of often-complex projects.

The work is deadline driven and requires rapid and frequent communications, not only between individuals, but also by computer and/or telephone for much of the day.

Work week regularly exceeds 40 hours per week.

The position is a 100% remote.

This position requires a flexible work schedule.

Stringent deadlines from sponsor organizations/companies to meet deadlines may require overtime including occasional evening and weekend overtime.Application Process: The application process may include completion of a variety of online assessments to obtain additional information that will be used in the evaluation process. These assessments may include Work Authorization, Cover Letter and/or others. Any assessments that you need to complete will appear on your screen as soon as you select “Apply to this position”. Once you begin an assessment, it must be completed at that time; if you do not complete the assessment, you will be prompted to do so the next time you access your “My Jobs” page. If you select to take it later, it will appear on your "My Jobs" page to take when you are access ready. Please note that your application will not be reviewed, and you will not be considered for this position until all required assessments have been completed.University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, religion, color, national origin, sexual orientation, gender identity, sex, age, protected veteran or disabled status, or genetic information.