SummaryThe Clinical Trials Budget Specialist III is responsible for developing clinical trial budgets of the highest complexity with an emphasis on quality, training, monitoring, and the development of tools for study team use. The Clinical Trials Budget Specialist III will regularly work independently with study teams to develop and execute budgets and will support the goals of the Clinical Research Operations Quality Program.
Primary Responsibilities - Oversee clinical trial budget development, including review of protocols and relevant documents to ensure that appropriate costs and allocation of institutional resources are fully captured in the budget.
- Lead study teams in coordination with departments, investigators, research staff, supporting administration, and sponsors/funding agencies to ensure complete, comprehensive, accurate and timely budgets.
- Lead correspondence and meetings with stakeholders to facilitate ongoing budget discussions. This will include documenting progress and providing updates to affected parties.
- Ensure research rate schedules are current and appropriately applied to study budgets.
- Facilitate budget negotiations with sponsors, academic sites, and other extramural funding sources to reach an agreement on budget and payment terms.
- Responsible for entering and maintaining the budget and other financial information into OnCore Clinical Trial Management System (CTMS) to maintain proper reimbursement and revenue integrity.
- Perform pre-award quality assurance to verify completion of required elements prior to Medicare Coverage Analysis.
- Lead the development and dissemination of clinical research education opportunities as needed in accordance with federal regulations, institutional policies, and specific protocol requirements.
- Lead the development of departmental policies, procedures, and resources to support clinical trial financials workflows.
- Provide excellent customer service while maintaining accurate results in a fast-paced, deadline-driven team environment.
- Engage in special projects and ad hoc duties as a member of the administrative team.
- Other duties as assigned.
Knowledge - Skills - Abilities- Extensive knowledge of clinical trials, including budget development and financial management required.
- Budget negotiation experience is required.
- Knowledge of research billing compliance, coverage analysis, institutional and departmental policies and procedures required.
- Data utilization, complex problem solving, critical thinking, resource management, and project management skills are necessary.
- Experience with OnCore CTMS and Microsoft Excel are required.
- Excellent oral and written communication skills are essential.
QualificationsAppropriate experience may be substituted for education on an equivalent basis.
Minimum Required Education: Bachelor's degree
Minimum Required Experience: 6 years
Physical RequirementsWork requires occasionally lifting moderate weight materials, standing, or walking continuously.
Work EnvironmentOccasional exposure to dust, noise, temperature changes, or contact with water or other liquids. Work is performed in an environmentally controlled environment.
Sensory AcuityAbility to detect and translate speech or other communication required. May occasionally require the ability to distinguish colors and perceive relative distances between objects.
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