Clinical Trials Budget Specialist II - Research Office

About the role

Under limited supervision, the Clinical Trial Budget Specialist II develops budgets for clinical trials of increasing complexity, with an emphasis on quality, training, and monitoring. The Clinical Trial Budget Specialist II will coordinate the day-to-day study-related activities of the Clinical Research Operations Quality Program and will provide project management support to teams to develop and finalize clinical trial budgets. Primary Responsibilities The Office of Research helps to facilitate life-saving biomedical research at the Medical College of Wisconsin. Nine distinct units provide specialized support to meet the administrative needs of our investigators and research staff, and together we coordinate, regulate, and monitor research studies. Within our Administrative Unit, the Clinical Research Operations Quality Program provides support such as regulatory guidance, budget support, research systems assistance, and resources to facilitate clinical research operations. Under limited supervision, the Clinical Trial Budget Specialist II develops budgets for clinical trials of increasing complexity, with an emphasis on quality, training, and monitoring. The Clinical Trial Budget Specialist II will coordinate the day-to-day study-related activities of the Clinical Research Operations Quality Program and will provide project management support to teams to develop and finalize clinical trial budgets. Primary Functions Develop clinical trial budgets, including review of protocols and relevant documents to ensure that appropriate costs and allocation of institutional resources are fully captured in the budget. Work in collaboration with ancillary teams, departments, investigators, research staff, supporting administration, and sponsors/funding agencies to create complete, comprehensive, accurate and timely budgets. Ensure appropriate research rates are applied to study budgets. Independently develop, negotiate, and finalize budgets of moderate complexity with sponsors, academic sites, and other extramural funding sources to reach an agreement on budget and payment terms. Submit and maintain 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. Communicate and meet with stakeholders to facilitate ongoing budget discussions and provide updates to relevant parties. Use advancing knowledge to develop and disseminate clinical research education as needed in accordance with federal regulations, institutional policies, and specific protocol requirements. Apply knowledge of clinical research to provide recommendations and direction to clinical research teams to ensure budgetary compliance throughout all phases of the Clinical Trial Financials Lifecycle. Develop and support the formulation of program policies, procedures, and resources to establish and enhance 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 Fundamental knowledge of clinical trials, including budget development and financial management is expected. Knowledge of research billing compliance, coverage analysis, institutional and departmental policies and procedures preferred. Data utilization, complex problem solving, critical thinking and resource management skills are necessary Proficiency using Microsoft Excel is required. Experience with OnCore CTMS preferred. Excellent oral and written communication skills are essential.

Requirements

• Appropriate experience may be substituted for education on an equivalent basis.
• Minimum Required Education: Bachelor's degree
• Minimum Required Experience: 4 years
• Preferred Experience: Experience with clinical research preferred
• Physical Requirements
• Work Environment
• Sensory Acuity
• Ability to detect and translate speech or other communication required. May occasionally require the ability to distinguish colors and perceive relative distances between objects
• #LI-AV1
• Why MCW?
• Outstanding Healthcare Coverage, including but not limited to Health, Vision, and Dental. Along with Flexible Spending options
• 403B Retirement Package
• Competitive Vacation and Paid Holidays offered
• Tuition Reimbursement
• Paid Parental Leave
• Employee & Family Assistance Program (EFAP)
• Pet Insurance
• On campus Fitness Facility, offering onsite classes
• Additional discounted rates on items such as: Select cell phone plans, local fitness facilities, Milwaukee recreation and entertainment etc.
• For a brief overview of our benefits see: Benefits Overview
• For a full list of positions see: MCW Careers
• At MCW all of our endeavors, from our internal operations to our in

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