• Clinical Research Financial Specialist

    Job ID
    12320
    Type
    Regular Full-Time
    Company
    Seattle Cancer Care Alliance
    Location
    US-WA-Seattle
    Category
    Clinical Research Support Services
  • Overview

    The Seattle Cancer Care Alliance (SCCA), located in Seattle, Washington, is part of a dynamic collaboration among three organizations known nationally and internationally for their patient care and research: Fred Hutchinson Cancer Research Center, University of Washington, and Seattle Children's. Over the past 25 years, these institutions have worked together to support their mission of adult and pediatric oncology patient care services, research and education.

     

    The Clinical Research Financial Specialist is responsible for sponsored research administration including clinical research budget development, on-study budget management and budget closeout for clinical research studies conducted in collaboration with or by SCCA Research Integration (RI). 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 requires in-depth knowledge and experience in clinical research coordination, budgeting, compliance, and regulations. This position reports to the Clinical Research Business Office Associate Director.

    Responsibilities

    Clinical research budget development and management

    • Performs comprehensive and independent review of all documents and information related to the research study funding, including study budget, protocol, consent form, contract, and other supporting documentation
    • Exercises judgment and discretion in interpreting complex oncology clinical trial protocols to develop study-specific budgets that account for all procedural and resource costs
    • Independently negotiates successful clinical trial budgets and payment terms with study sponsors; recommends changes to contract language when necessary
    • Uses Clinical Research Budget and Billing (CRBB) tools and resources and teaches others to use these tools
    • Analyzes study budgets, contracts and informed consents for thoroughness, appropriateness and consistency of language prior to research study approval and submission
    • Reviews and recommends approval of payment terms and services provided to study subjects
    • Assures that post-award processes are complete, including final report to sponsors, budget closeout, etc.
    • Develop policies and processes to assure that all clinical services and procedures on research studies are billed appropriately, and that collections are pursued regularly and accurately
    • Successfully identifies and communicates budget terms and concerns to management at RI, assuring that final contracts are financially and contractually consistent with goals of the study
    • Prepares interim financial reports to RI management and external partners
    • Assures timely resolution of all contract issues between sponsors and RI
    • Ensures each study’s consent form delineates research care and usual care related to payment responsibilities in alignment with coverage analysis and study budget
    • Works effectively with providers and staff to assure that research projects stay on time and on-budget with projected project goals and contractual terms
    • Partners with fiscal and research staff to conduct post-award budget management and analysis
    • Works effectively with internal partners to ensure clinical trials are performed in accordance with institutional requirements for billing compliance
    • Assists in study-related financial audits as necessary
    • Coordinates and communicates with appropriate offices involved in the review and negotiation of clinical trial budgets and contracts

    Clinical research budget policy development and education

    • Develops and leads on-going education regarding research budgeting and billing policies, regulations, and compliance matters
    • Identifies, analyzes, implements and communicates RI policies concerning research budgeting and pricing policies for pertinent research studies
    • Identifies opportunities for improvement for pre-study, on study and study closeout budgetary matters; implements changes to stabilize and strengthen compliance
    • Effectively serves as liaison between the project team, industry and other stakeholders regarding financial aspects of the study.
    • Participates in Program and Institutional meetings as needed

    Clinical Trial Financial Coverage Analysis

    • Maintain a detailed understanding of Medicare Clinical Trial Policy (NCD 310.1) and related guidance documents
    • Performs coverage analysis of clinical trials for clinical research budgets in collaboration with clinical trial investigators and their staff, assuring compliance with federal billing regulations and guidelines and institutional policies and standards
    • Serves as a liaison between Research Integration and the Principal Investigator and study teams in support of knowledge sharing related to Coverage Analysis; appropriately representing the interests of SCCA and our patients
    • Represents Research Integration’s Clinical Research Business Office (CRBO) as a content expert related to Coverage Analysis in PI Review meetings, Implementation meetings, Department huddles and in daily interactions with internal and external customers
    • Other duties/projects as assigned

    Qualifications

    Required:

    • Bachelor’s degree in business, finance or medical-related field. Equivalent, related work experience may be substituted for degree requirement
    • Minimum five years’ experience with clinical research budget development, clinical research coordination, or related research or healthcare experience
    • Strong fiscal and compliance background
    • Experience with medical billing processes or related human subjects’ research and/or healthcare experience
    • Ability to work effectively and efficiently as a team member
    • Ability to independently prioritize and organize work
    • Demonstrated diplomacy and effective communication with physicians, colleagues and patients
    • Strong written and oral presentation skills
    • 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 expertise in Microsoft Excel, CTMS and other budgeting/financial tools
    • Ability to communicate effectively with all levels of management and medical research staff
    • Ability to translate technical financial and scientific data into understandable information for many users at varying levels of experience

     

    Preferred:

    • Experience negotiating clinical trial budgets and payment terms
    • Experience with sponsored research administration
    • 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
    • Understanding related to principles of hospital coding and related fee schedules
    • Knowledge of the Medicare Clinical Trials Policy (NCD 310.1) and other federal, state and institutional clinical research regulations
    • Strong working knowledge of Microsoft Office Suite.

    Our Commitment to Diversity

    We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at escmail@fredhutch.org or by calling 206-667-4700.

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed