1+ months

STUDY START-UP SPECIALIST

University of Washington
Seattle, WA 98104

STUDY START-UP SPECIALIST

Req #: 172662
Department: ONCOLOGY
Job Location: South Lake Union
Posting Date: 12/10/2019 
Closing Info: Open Until Filled 
Salary: Salary is commensurate with experience and education 
Shift: First Shift 

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. All of which has allowed the UW to be nationally recognized as a Great College to Work For for six consecutive years. 

The Division of Medical Oncology in the Department of Medicine has an outstanding opportunity for a full-time Study Start-up Specialist.

This position is responsible for clinical research budgeting and revenue cycle strategy for the Phase 1 Program in Division of Medical Oncology. This position works with minimal supervision and negotiates optimal pricing and payment terms with industry sponsors. At any given time, up to 15 research projects may be in various stages of development and/or negotiation.  This position requires the ability to understand clinical research coordination, revenue cycle development, budgeting, compliance, and regulations.  This position reports to the Finance Manager and works closely with the Senior Budget Specialist and faculty leadership in the division.

Medical Oncology is a Division within the Department of Medicine.  The Divisions primary mission is 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 Medical Oncology is primarily located in the Seattle Cancer Care Alliance (SCCA), on the Fred Hutchinson Cancer Research 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.  This position interacts closely with multiple process partners, including SCCA, UW, and FHCRC clinical and administrative departments, and multiple regulatory committees.

The Phase 1 clinical research program has an annual operating budget of $5.5 million, 2 faculty and 33 research and administrative staff.  At any given time the Phase 1 Program has over 35 open studies with over 70 enrollees, which generates critical research funding and discovery mechanisms as well as bringing much-needed investigational treatments to oncology patients with few or no other options.

This position is responsible for ensuring financial accountability and billing compliance for the Phase 1 Program under the direction of Finance Manager.  The Program Operations Specialist manages study-specific strategic development of coding and billing infrastructure and compliance assessment related to clinical research revenue cycle

Clinical Trial Budget Development, Revenue Cycle, and Financial Risk Management

  • Perform comprehensive and independent review of all funding information related to individual research studies, including but not limited to study budgets, protocols, consent forms, contracts, and other supporting documentations.
  • Schedule, coordinate, and communicate overall budget and contract submission activity
  • Prepare and submit eGC1s in accordance with OSP requirements and deadlines
  • Ensure SFI compliance is completed and required approvals are received by OSP deadlines
  • Coordinate with research staff to ensure each studys consent form delineates research care and standard of care.
  • Interpret complex oncology clinical trial protocols to develop study-specific budgets that account for all procedural, regulatory and operational costs.
  • Independently negotiate successful clinical trial budgets and payment terms with study sponsors.
  • Provide effective strategic, intellectual, and technical assistance to faculty and staff on clinical research revenue cycle policies, compliance, and regulatory matters.
  • Interpret, analyze, and implement all institutional, state, and federal policies related to clinical research fiscal cycle administration including Medicare Clinical Trials Policy and Medicare Secondary Payer Rule; act as Division expert on such polices.
  • Coordinate and communicate with UW and SCCA 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 Seattle Cancer Care Alliance Research Implementation Office
  • Assist the Finance Manager with developing start-up tools and metrics

    Operational Support

  • Assist with post-award duties, including but not limited to auditing and reconciling all payments prior to study budget closure
  • Ensure billing compliance by tracking research bills

    Education and Communication

  • Act as a resource for billing compliance questions for research staff. Educate research staff on billing requirements for individual studies
  • Assist the Senior Budget Specialist 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

    As a UW employee, you will enjoy generous benefits and work/life programs.  For detailed information on Benefits for this position, click here.

    REQUIREMENTS:

  • Bachelor's Degree in Business, Science or Health-related field plus a minimum two years experience with clinical research budget development, clinical research coordination, or related research or healthcare experience.

    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 prioritize and organize work independently
  • Demonstrated skill in using Microsoft Excel
  • Ability to have a flexible work schedule

    Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.

    DESIRED

  • Experience in an academic medical center
  • 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, including the CMS National Coverage Decision, and other federal, state and institutional clinical research regulations
  • Experience with research billing with the ability to interpret the Billing Grid
  • 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.

    CONDITIONS OF EMPLOYMENT

    Application Process:
    The application process for UW positions 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 Workforce 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 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.
  • Committed to attracting and retaining a diverse staff, the University of Washington will honor your experiences, perspectives and unique identity. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable and welcoming.

    The University of Washington is a leader in environmental stewardship & sustainability, and committed to becoming climate neutral.

    The University of Washington is an equal opportunity, affirmative action employer. To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 / 206-543-6452 (tty) or dso@uw.edu.


    Categories

    Posted: 2019-12-05 Expires: 2020-02-13

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    STUDY START-UP SPECIALIST

    University of Washington
    Seattle, WA 98104
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