Clinical Research Financial Specialist
- Location: Seattle, WA
- Posted: Dec 14, 2018
Job Description
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 studys 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 Integrations 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:
Bachelors 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.
Employment Type
- Regular Full-Time