About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 5000 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 nationâ€™s 20 leading cancer centers that develops and institutes standards of care for cancer treatment.
Coordinates and oversees the development of coverage analyses and budgets for both industry sponsored and non-industry sponsored clinical trials. Works with third party vendors as necessary to supply clinical trial documentation, prioritize work queues, and assist with budget development. Liaises between external budget developers and COH departments to determine suitable cost allocations for unique clinical trial procedures. Works with Principal Investigators and study teams to finalize clinical trial budgets and obtain approval of coverage analyses, budget estimates, or detailed budgets. 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 patient finance services is supplied with finalized documentation.
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 budget development issues, including but not limited to budget estimates and non-qualifying trial assessments. Is charged with ensuring that incremental costs of clinical research are covered per institutional policy and guidelines while applying clinical research 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 finalize and gain approval of coverage analyses and budgets while tracking all appropriate data metrics. Must understand the clinical trial and the protocol in order to review coding with PI.
- Performs critical assessment of each project to confirm funding source and assure that negotiation is consistent with institutional guidelines.Performs ongoing assessment of current budgets to identify established precedent pricing.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 Director.
- 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
- Review study protocols for financial and resource feasibility.Carry out periodic reviews of study files to ensure administrative quality, compliance, and consistency across clinical trials
- Review protocol amendments for any revisions affecting the budget; updates budget as necessary or re-prioritizes for additional development by a third party vendor.
- Assist with ongoing review of internal processes to streamline roles and responsibilities; execute process changes or identify resources to accomplish projects and oversee to completion.
- Assists with evaluation of evolving issues specific to sponsor costs and collaborative decisions regarding single-study budget exceptions.
- Prepare reports and advise on feasibility and cost effectiveness.
- Participate in the development of new data systems and tools for electronic clinical trials, financing, documentation, and administration.
- 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 research subjects and research personnel protections.
- Conduct special projects and perform additional duties as assigned by the Director.
Minimum Education and Skills Required for Consideration:
- *Bachelorâ€™s Degree or equivalent combination of education and experience.
- Five years of 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 a clinical trial
- Must be familiar with Medicare regulations, guidelines, policies
- Experience budgeting and estimating clinical trials costs is a plus
- Must have working knowledge of clinical trials and general study budgeting techniques
- Medical Terminology
Preferred Education and Skills:
- 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
- Clinical trial budgeting, coverage analysis development, budget negotiations
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.
Meet Some of City of Hope's Employees
Sr Prospect Research Analyst
Working within the Foundation and Relations Department, Libby prepares and provides frontline fundraisers with prospective donor profiles—financing City of Hope’s outstanding patient care and clinical research.
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