The Clinical Trial Budget and Activation Specialist supports the research office's pre-award and activation functions, performing Medicare Coverage Analyses, developing and negotiating clinical trial budgets, and serving as the institution's financial representative with sponsors and CROs. This role manages assigned studies through the full pre-activation workflow, coordinating with investigators, coordinators, finance, contracting, and regulatory teams to resolve billing compliance questions and remove activation barriers.
The incumbent applies CMS coverage guidance, protocol requirements, and institutional policy to budget development, negotiates payment terms and pass-through costs, and supports financial compliance documentation and process improvement initiatives. Responsibilities Supports departmental research teams and faculty with the review and submittal of research proposals, contracts, and necessary research materials to maintain accuracy, completeness and compliance with applicable policies, procedures and regulations.
Facilitates compliance with necessary collaborating offices (such as Institutional Review Board, Institutional Animal Care and Use Committee, Environmental Health and Safety, Compliance and Audit Services and Research Finance) throughout the lifecycle of the research project. Facilitates signature & approvals of proposal materials on behalf of the institution as allowed within Signature Authority Policy. Identifies and disseminates active funding opportunities to the research community.
Initiates study registration within the pre-award and post-award systems, as applicable. Represents D-H central research operations by addressing any research administration related inquires/requests with sponsors. Acts as the primary central research liaison to PI and research staff.
Trains and mentors departmental research staff on operational, service and compliance aspects of administering research study/award. Assists Research Finance with creation of policies, procedures, and training materials to reinforce institutional standards for administering research project/ awards. Performs other duties as required or assigned.
Clinical Trials Office: Perform Medicare Coverage Analyses for all studies, including entering the appropriate HCPCS and CDM codes for items and services to complete the Billing Grid and determining if conventional care items/services qualify for Medicare coverage. Works closely with other departments such as Revenue Management and Compliance and Auditing to accurately conduct, review, and implement Medicare Coverage Analyses.
Qualifications Bachelor’s degree in a related field or the equivalent in education and experience required. Four+ years research administration (or experienced research coordinator) work experience preferred. Experience in a healthcare or academic research administration setting and knowledge of electronic research administration systems Clinical Trials Office: Working knowledge of Clinical Trials Management Systems (CTMS), subject calendar development, Medicare Coverage Analysis, billing/research compliance and/or research budgeting/contracting required.
Sponsored Projects Office: Working knowledge of federal regulations relating to grants, contracts, and research compliance a well as non-federal sponsored research Ability to work effectively, independently and as a member of a team. Ability to exercise judgment, initiative, and discretion and to interact with staff and outside agencies in a professional manner. Technological proficiency including email, calendars, databases, and Office suite Excellent communication, organization, and customer service skills Required Licensure/Certifications None