Senior Clinical Trials Budget Specialist -- Division of Hematology & Oncology

Senior Clinical Trials Budget Specialist

The Department of Medicine, Division of Hematology & Oncology has an outstanding opportunity for a Senior Clinical Trials Budget Specialist to join their central administration finance team.

Reporting to the Clinical Research Budget Manager and under the leadership of the Division Associate Administrator of Finance and Research, the Senior Clinical Trials Budget Specialist is responsible for implementing complex clinical research budgeting and revenue cycle strategy, development, and oversight across all Division Teams including research faculty and staff within the Division of Hematology and Oncology. Specifically, this position oversees optimal revenue recovery and payment terms for investigator initiated and industry sponsored clinical trials, directing and training teams in revenue recovery, and ensuring regulatory compliance and fiscal accountability. At any given time, up to 300 research projects may be in various stages of activity. This position requires in-depth knowledge and experience in OnCore, EPIC, clinical research coordination, revenue cycle development, budgeting, compliance, and regulations.

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. The Senior Clinical Trials Budget Specialist is eligible to be considered for a telework fully remote work schedule, though, this position works with on-site teams and project work visits may be required at affiliate locations.

Key Responsibilities

• Perform comprehensive and independent review of patient activity, in comparison to the Clinical Trial Agreement, perform complex financial reconciliations to ensure full revenue recovery.
• Using EMR EPIC, Clinical Trials Management Software (CTMS) OnCore, and financial system Workday, perform complex external sponsor invoicing, adhering to the terms of the Clinical Trial Agreement. Provide expert training and knowledge of CTMS OnCore for financial reconciliation of studies that are operational in that system.
• Manage and oversee the post award patient activity and billing review. Ensure patients were not billed for research procedures as listed in the Medical Coverage Analysis. Review billing grid and calendars in OnCore to ensure they are complete and correct to avoid invoicing or patient activity entry delays.
• Interpret and analyze budgets both during active period and post closure, to provide feedback to budget building teams on areas of concern and strength. Collaborate with faculty, research and fiscal staff in the development of clinical research revenue cycle policies. Identify and assist faculty to mitigate budget deficits, including communication with sponsor for amendments.
• Monitor and assess program compliance around clinical trial budget development, identifying opportunities for improvement and implementing changes to stabilize and strengthen compliance.

• Interpret, breakdown, and orient disease team staff to complex oncology clinical trial protocols.
• Develop study-specific budgets that account for all procedural and labor costs, ensuring full cost recovery, identifying the financial weaknesses and strengths in the contract.
• Work with start up teams to inform them on continuous process improvements with relation to deficit budgets and calendar builds in OnCore. Advocate for changes in start up that affect the downstream teams and create efficiencies and simplify the revenue recovery process. Direct, advise and instruct start up team when to agree to concessions and when to stop negotiations during the budgeting process.
• Perform complex Medicare Coverage Analysis in accordance with Medicare Clinical Trial Policy, and all relevant UW Medicine clinical research budgeting and billing policies and procedures.
• Understand and interpret all institutional, state, and federal policies related to clinical research budgeting and billing; act as Division expert on such policies. Demonstrate comprehensive knowledge of CMS and FDA regulations and guidelines to ensure the University of Washington is compliant with Federal and State patient billing laws.
• Understand pricing for procedures University of Washington, Fred Hutch Cancer Center, and other partner institution service departments. Lead teams when price fluctuations affect budgets, suggesting amendments or modifications to ensure full cost recovery.
• Develop tools and metrics with the goal of increasing study budgeting process efficiencies and streamlining operations. Develop language for teams to provide to sponsors as reasoning for expense category and amount. Unify the Division in how the Division approaches sponsor issues to ensure a unified approach and greater success rate of awards.
• 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 Clinical Research Services. 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.

• Direct the work of the Clinical Trial Post Award Specialists.
• Support the Research Budget Manager with hiring, training and mentoring clinical trial post award specialists.
• Train and mentor the clinical trial post award specialists by assisting in troubleshooting, auditing studies and providing regular guidance and feedback to improve revenue recovery.
• Direct and train staff to perform comprehensive feasibility analysis, both from a research team capacity and capability aspect, and a financial aspect.

Perform other related duties/projects as assigned.

Required Qualifications

To be considered for this opportunity your application must demonstrate you meet both the minimum qualifications and additional qualifications listed below. Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration.

Minimum Qualifications

• Bachelor's Degree in Business, Science, Health, or related field
• Four years of experience with clinical research budget development, clinical research coordination, or related research or healthcare experience.

Additional Qualifications

• Experience with OnCore and EPIC
• Demonstrated ability to work effectively and efficiently in a group environment, and to prioritize and organize work independently.
• Exceptional organizational and customer service skills.
• Strong written and oral presentation skills, including demonstrated ability to convey complex policy, financial and scientific/technical information in a manner that is understandable to a wide audience.
• Ability to communicate effectively with all levels of faculty, management and clinical research staff, including to teach and mentor others in group settings, in one-on-one sessions, and remotely.
• Demonstrated skill in using Microsoft Excel.

Preferred Qualifications

• Experience in an academic medical center, as a research study coordinator, and/or in oncology clinical research
• Experience negotiating clinical trial budget and payment terms
• 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 Suite

Working Conditions

• 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.
• Stringent deadlines from sponsor organizations/companies to meet deadlines may require overtime or a flexible work schedule including occasional evening and weekend overtime.
• This position is eligible to telework 100% remote.

About the Team

The University of Washington's Division of Hematology & Oncology includes 150+ staff and 130+ faculty members located at the UW Medical Center, the Fred Hutchinson Cancer Center (FHCC), and the VA Puget Sound Health Care System. As the premier hematology/oncology program in the Pacific Northwest, we balance the twin aims of innovative, life-saving research and knowledge-driven, patient-focused cancer care. Over the past 40 years, members of the Division have developed the world's leading bone marrow transplant program. In addition, members of the Division have made substantial contributions to many other areas of cancer treatment, including the use of tumor vaccines, cellular therapy for cancer, antibody-based treatments, and novel forms of chemotherapy and hormonal therapy. Our division is deeply committed to maintaining its position as one of the leading centers for research and treatment of cancer in the world.

Compensation, Benefits and Position Details

Pay Range Minimum:

$96,000.00 annual

Pay Range Maximum:

$119,100.00 annual

Other Compensation:

-

Benefits:

For information about benefits for