- Duarte, CA
About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 6000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.
Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers that develops and institutes standards of care for cancer treatment.
Coordinates and develops coverage analyses and budgets for both industry sponsored and non-industry sponsored clinical trials, along with any corresponding amendments. Liaises between external sponsors and COH departments to determine suitable coverage justifications and cost allocations for unique clinical trial procedures. As needed, works with Principal Investigators and study teams to finalize clinical trial budgets and obtain approval of coverage analyses, budget estimates, and/or detailed budgets. As needed, negotiates budgets with clinical trial sponsors on behalf of the institution to ensure optimal cost efficiency. Tracks all relevant data and ensures both contracting and Revenue Integrity teams are supplied with finalized documentation. Enters, maintains and/or reviews financial data from finalized clinical trial agreements and budgets into the OnCore Clinical Trial Management System (CTMS).
Provides day-to-day administrative support to Principal Investigators, clinical research nurses, research site managers, clinical research coordinators, departmental business directors and other stakeholders in resolving coverage and budget development issues, including but not limited to budget estimates and qualifying trial assessments. Charged with ensuring that incremental costs of clinical research are covered per institutional policies and guidelines while applying clinical research billing compliance expertise pertaining to all applicable payers.
The position includes the general development and ongoing refinement of administrative infrastructure for the management of financial activity associated with for-profit corporate sponsorship as well as non-industry submissions pertaining to clinical trials.
The position integrates diverse elements of clinical trial management and requires creativity, teamwork, and collegiality to develop and maintain sound fiscal and related administrative systems.
Key Responsibilities include:
- Coordinate with all relevant groups to draft, finalize and gain approval of coverage analyses and budgets while tracking all appropriate data metrics. This includes documenting qualifying clinical trial status, researching coverage limitations, verifying expected medical necessity, and assigning costs for clinical and non-clinical components of each trial. Must understand the clinical trial and corresponding protocol in order toCoordinate with all relevant groups to draft, finalize and gain approval of coverage analyses and budgets while tracking all appropriate data metrics. This includes documenting qualifying clinical trial status, researching coverage limitations, verifying expected medical necessity, and assigning costs for clinical and non-clinical components of each trial. Must understand the clinical trial and corresponding protocol in order to determine coding and charge determinations. Enter and/or review financial data in OnCore and initiate the sign-off process of the OnCore calendar/financial console.
- Review protocol amendments for any revisions affecting the coverage analysis and/or budget; updates previously documented information as necessary
- Performs critical assessment projects to confirm funding source and assure that negotiations will be consistent with institutional guidelines. As needed, performs detailed analyses of current coverage analyses or budgets to establish precedent pricing and better drafting and development techniques. Assesses comparable nature of projects by factors such as study phase or disease-type to ensure appropriate costing.
- Analyze new protocols, letters of intent, synopses, etc., received from sponsors, review committees or PI/study teams to determine coverage analysis/budget necessity and/or prioritization in coordination with department leadership.
- Interacts with sponsor officials to solve budget issues such as budgetary changes, target patient accrual changes, requests for additional funds, or general cost disputes.
- Compile non-detailed budget estimates via internal estimation tools, as needed and when applicable to sponsor guidelines. Work with third-party vendors if detailed estimates are required
- Assists with evaluation of evolving issues specific to sponsor costs and collaborative decisions regarding single-study budget exceptions.
- Participate on administrative committees as requested to improve the administrative understanding and support of clinical trials. Represent City of Hope at national and regional professional meetings as necessary.
- Maintain general knowledge of billing compliance, as well as research subjects and research personnel protections.
- Conduct special projects and perform additional duties as assigned by the department leadership (may represent more than 5% effort in certain circumstances).
Basic education, experience and skills required for consideration:
• Bachelor’s Degree or equivalent combination of education and experience.
- Three years of related budget experience working in research administration, a Contract Research Organization, pharma or biotech industry, a medical or clinical practice arena, or health insurance industry.
- Must have working knowledge of clinical trials
- Must be familiar with HCPCS / CPT codes
- Must understand what is standard of care or routine care and what is considered research-related in the context of clinical trials
- Must be familiar with Medicare regulations, guidelines, policies
- Must have working knowledge of medical terminology specific to oncology clinical trials and general study budgeting techniques and coverage analysis techniques
- Knowledge of Good Clinical Practice Guidelines, ICH Guidelines, FDA and HIPAA regulations, Medicare policy on Routine Costs in Clinical Trials
- Knowledge of common budgeting practices and general time/effort allotments
- Knowledge of common coverage analysis practices in an oncology setting
- Knowledge of clinical trial coverage analysis and/or financial data entry into OnCore Clinical Trial Management System.
City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.
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