Indiana University Purdue University Indianapolis (IUPUI)
Location: Indianapolis, Indiana,
Internal Number: 302508
CLINICAL TRIALS OFFICE (UA-CLTO-IUINA)
The mission of the Coverage Analysis Team (CAT) within the Office of Clinical Research is to streamline clinical research study activation while acting as an institutional safeguard to ensure clinical research studies comply with applicable federal, state, and local laws and regulations related to clinical research budgeting and billing. The Coverage Analysis Team supports clinical research faculty and staff and helps navigate the clinical research study activation and study amendment workflows within the Clinical Research enterprise. CAT members perform new and legacy clinical research coverage analysis in both the Clinical Research Management System (CRMS) and legacy systems (e.g., MS Excel, etc.). CAT members will be campus experts in clinical research study activation, particularly regarding budgeting and billing compliance, and are ambassadors in encouraging and supporting adoption of proper workflows.
The Coverage Analyst is considered a developing analyst gaining skills in Coverage Analysis, budget development, project management, and other assets needed to be an effective member of the CAT. Initially, this position will have no direct reports; however as the needs expand, it is possible this position would provide supervision, mentorship, and guidance to junior level staff and/or contract resources.
Performs assignments in accordance with current Standard Operating Procedures (SOPs) and works with CAT and OCR leadership.
Reviews and assists in management of intake procedures to ensure accuracy of documents received and associated data entry.
Serves as liason with other research administrators to support and facilitate clinical research study activation, budget development, informed consent review and guidance, and OnCore navigation.
Fosters effective and cooperative relationships within the Coverage Analysis Team, as well as with collaborators in contracting, IRB, departmental and other administrative research units.
Works independently as well as effectively in a team environment.
Reviews clinical trial proposals/protocols to determine if each new study is a qualified clinical trial pursuant to CMS policy; creates coverage analysis & billing plan for each clinical trial in accordance with Medicare rules and performs document review for alignment for each study.
Reviews, prepares, and generates detailed Coverage Analysis using clinical trial documents (i.e., protocol, research intake form, contract, informed consent) to determine if items/services provided for the study are deemed qualified as a clinical trial pursuant to the Medicare Clinical Trial Policy 310.1, National and Local Coverage Determination or otherwise approved by CMS.
Assesses compliance with other regulatory requirements including FDA and NIH.
Participates in study specific team meetings to build relationships with research teams and administrators to support and facilitate clinical research study activation, budget development, informed consent review and guidance, and OnCore navigation.
Assists with Clinical Research Financials special projects as needed.
Maintains required competencies and current knowledge in relevant research billing rules and guidance, database management, Outlook, and Excel.
Under the direction and guidance of Coverate Analyst IIs and Assistant Director of Finance, works with key stakeholders within IU and its clinical research affiliates and engages in collaborative efforts with respect to various financial and compliance constructs.
Identifies needs and reports issues concerning regulatory compliance and financial stability. The level of decision making will be more technical based.
Responsible for tasks related to ensuring the accuracy of clinical research financials. Errors in processes could impact the financial stability of research projects. As well, these processes mitigate risk to the university and its partners. As such, poor performance could expose these entities to financial repercussions associated with lack of compliance.
Acts as part of the CAT responsible for ensuring compliance with Federal regulations and financial prudence of the university. Errors will impact the fiscal viability of the clinical research enterprise.
Following established procedures, performs periodic fiscal analysis of income statements, balance sheets, and cash flows and compiles trends to guide financial decisions.
Provides general financial analysis support using measures such as past financial performance, economic conditions, price, yield, stability, and investment risk.
Interprets fiscal policies and acts as a resource to department.
May serve as fiscal delegate for department accounts.
Presents findings using tools such as spreadsheets, charts, graphs, and technical reports.
Bachelor's degree in accounting, finance, or a related field.
1 year in finance, financial administration, accounting, or a related field.
Experience working within a medical or clinical research setting.
Combinations of related education and experience may be considered.
LICENSES AND CERTIFICATES
CCRP, SOCRA, ACRP or similar research related certificate.
Ability to analyze and interpret financial data.
Demonstrated\s analytical skills.
Articulate and responsive to colleagues.
Demonstrates a high level of accuracy, even under pressure.
Performs work independently with minimal supervision.
Demonstrates time management and priority setting skills.
Strong computer skills.
Ability to learn quickly.
Excellent written and verbal communication skills.
Ability to establish and maintain cooperative and mutually supportive relationships with faculty, administrators, staff, and other units both internally and externally to the University.
Excellent organization skills.
Strong skills in multi-tasking, and customer service.
Ability to be flexible and adapt in a dynamic environment.
Knowledge of pre-award activities.
Knowledge of medical terminology.
Knowledge of the medical/research regulatory environment.
Knowledge of budgeting processes.
Possesses IRB and protocol experience.
Experience with the following equipment: Computer, telephone, fax, scanner, and copier.
Working Conditions / Demands
This role requires the ability to effectively communicate and to operate a computer and other standard office productivity equipment. The position involves sedentary work as well as periods of time moving around an office environment and the campus. The person in this role must be able to perform the essential functions with or without an accommodation.
This position is grant funded with expected annual renewals. Renewals are contingent on the availability of grant funds.
Indiana University offers a wide array of benefits including:
Multiple plan options for medical insurance
Health Savings Account with generous IU contribution
Due to the COVID-19 pandemic, there may be differences in the working conditions as advertised in our standard job postings (e.g., the ability to travel from one campus to another, etc.). If you are invited for an interview, please discuss your questions or concerns regarding the working conditions at that time.
This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.
If you wish to include a cover letter, you may include it with your resume when uploading attachments.
New employees will be provided with information regarding Indiana University's COVID-19 vaccine policy, which includes the opportunity to request an exemption. To learn more, view our COVID-19 vaccine information page.
Equal Employment Opportunity
Indiana University is an equal employment and affirmative action employer and a provider of ADA services. All qualified applicants will receive consideration for employment based on individual qualifications. Indiana University prohibits discrimination based on age, ethnicity, color, race, religion, sex, sexual orientation, gender identity or expression, genetic information, marital status, national origin, disability status or protected veteran status. Indiana University does not discriminate on the basis of sex in its educational programs and activities, including employment and admission, as required by Title IX. Questions or complaints regarding Title IX may be referred to the U.S. Department of Education Office for Civil Rights or the university Title IX Coordinator.See Indiana University's Notice of Non-Discrimination here which includes contact information.
Campus Safety and Security
The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online. You may also request a physical copy by emailing IU Public Safety at email@example.com or by visiting IUPD.
About Indiana University Purdue University Indianapolis (IUPUI)
IUPUI, a partnership between Indiana and Purdue universities, is Indiana’s urban research and academic health sciences campus.
IUPUI’s mission is to advance the state of Indiana and the intellectual growth of its citizens to the highest levels nationally and internationally through research and creative activity, teaching and learning, and civic engagement.
By offering a distinctive range of bachelor’s, master’s, professional, and Ph.D. degrees, IUPUI promotes the educational, cultural, and economic development of central Indiana and beyond through innovative collaborations, external partnerships, and a strong commitment to diversity.