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Sr. Budget Specialist - Clinical Research (Washington, D.C.)
Category: Higher Education
Opportunity Type: Experienced
Country: United States
City: Washington, DC
Job Type: Full-time Salary
Huron Education has the world’s largest practice dedicated to serving the higher education industry. Our team of professionals, each with extensive knowledge and experience in the business of higher education and academic medical centers, delivers comprehensive services to the industry and partners with institutions to improve business performance across the enterprise. Our professionals draw from their experience working across various technology solutions, as well as strategic, financial, operational, and regulatory aspects of higher education to develop and implement the most effective solutions. Huron Education has worked with over 400 universities, academic medical centers, and research institutions to improve performance so they can continue their traditions of extraordinary achievement. The Huron Education team provides solutions across the following segments: Strategy and Operations, Research and Technology.
The Senior Clinical Research Budget Specialist assists the Research Office team in developing coverage analysis reports and study budgets for all clinical research studies, including but not limited to industry, federally sponsored, and locally (investigator) sponsored research. Primary responsibilities of the Senior Clinical Research Budget Specialist include conducting a thorough review of the study protocol, associated informed consent document(s), creating and/or utilizing a Coverage Analysis (CA) to draft a detailed study budget, and negotiating the terms of prepared budget documents (as applicable) with the study sponsor or their designated representative (e.g. Clinical Research Organization (CRO)).
LOCATION: Washington, D.C.
Job responsibilities of a Senior Budget Specialist include:
• Effective time management to meet deadlines;
• Ability to multi-task, working on the development or negotiation of multiple study budgets / coverage analysis reports concurrently;
• As needed, developing Coverage Analyses (CA’s) as outlined within the Coverage Analysis Specialist (CAS) role, and seeing the entire analysis process through to completion to ensure client deadlines are met;
• Conducting Quality Assurance (QA) reviews of CA’s completed by CAS’s;
• Excellent work ethic when drafting client-ready documents for review by the project supervisor / manager;
• Daily reporting on work planned and completed;
• Drafting study budgets using client and/or sponsor specific templates. Study budget development will require the following:
o Detailed review and analysis of clinical research protocols, informed consent forms, sponsor proposed study budgets, sponsor proposed study contracts (e.g.: Clinical Trial Agreements) , final CA, and other study documents to identify and confirm all billable procedures and services;
o Ability to interpret unclear or unstated language in study related documents that indicates sponsor payment for certain items, services, procedures, personnel, or equipment;
o Reviewing client policies and procedures in order to capture all relevant services for budgeting (outside of those captured on a final CA);
o Building study budgets on the Huron, client, and/or sponsor budget template (as applicable);
o Reviewing draft budgets with a Research Office Contracting Specialist, Research Office Coverage Analysis Specialist, client Coverage Analyst, or client contracts representative to ensure all budget terms are accurately reflected on the study contract;
o Providing draft budgets for quality review;
o Submitting draft budgets to client for review and sign-off by study team;
o Making revisions, as appropriate;
o Providing internally approved study budgets for negotiation (as applicable) with study sponsor;
o Representing Huron clients in the negotiation process while adhering to client guidelines on non-negotiable terms and conditions;
o Clearly strategizing and communicating a client’s financial position as it relates to the underlying clinical research protocol;
o Escalating negotiation impasses, as needed, to both internal Huron management and external client leadership.
• The Senior Clinical Research Budget Specialist will also be required to develop coverage analysis reports and/or quality assurance reviews of completed coverage analysis drafts as needed:
o Reviewing and analyzing clinical trial protocols, Informed Consent Forms, proposed study budgets and other trial documents to identify all items and services;
o Applying guidance from the Medicare Clinical Trial Policy (NCD 310.1) to each clinical trial that is analyzed;
o Identifying and providing CPT/HCPCS/APC/DRG codes to the relevant items and services;
o Reviewing Medicare coverage guidance for each item or service, e.g. National Coverage Decisions (NCDs), Local Coverage Decisions (LCDs), and other non-Medicare limitations on coverage;
o Researching approved medical guidelines to determine the routine or novel nature of each item or service;
o Providing the draft CA for quality review or directly completing the QA review ;
o Making revisions or providing feedback, as appropriate; messaging internal feedback in a clear and concise way;
o Providing a finalized CA to Huron and/or the client.
• Other duties as assigned.
Senior Clinical Research Budget Specialists in the Research Enterprise Solutions Services service line must provide evidence of the following:
• Bachelor’s degree or higher in a health/science related discipline (biology, public health, healthcare administration, nursing, etc.), or equivalent professional experience;
• Minimum of 4 years of work experience in a clinical research billing, pre-award services, or clinical trial administrative office setting.
• Experienced coverage analysis and budget development required.
o Emphasis on two or more of the following areas is preferred: clinical trial contract review, sponsor negotiation, clinical trial financial management, research charge segregation, clinical trial coordination, hospital coding, claims review
• Alternative but relevant experience in a Clinical Research Organization, the Pharmaceutical Industry, or other positions involving Clinical Trial Operations will also be considered
Preferred skills include:
• Experience in cost planning and Common Procedural Terminology (CPT) coding;
• Direct experience with budget negotiations experience a plus;
• Knowledge of federal regulations related to clinical research and billing compliance;
• Experience in healthcare compliance, general healthcare billing compliance, research billing, or research billing compliance;
• Knowledge of healthcare billing and claims processing a plus;
• Knowledge of Good Clinical Practice Guidelines, ICH Guidelines, FDA and HIPAA regulations.
• Experience working in an administrative/ business office of a university, hospital, or research institute.
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