Summary

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 Neuroscience Research Center and will provide project management support to teams to develop and finalize clinical trial budgets.

Primary Responsibilities

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 Neuroscience Research Program within the Wisconsin Institute of Neuroscience 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, 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.

Qualifications

Appropriate experience may be substituted for education on an equivalent basis.

Minimum Required Education: Bachelor’s degree

Minimum Required Experience: 4 years of experience in clinical research, including experience with industry-funded clinical trials, or experience working for an industry partner (e.g., pharmaceutical sponsor) with exposure to clinical trial budgets and contracts

Preferred Experience:

• Experience with clinical research

• Experience negotiating clinical trial budgets and contracts

• Experience reviewing and developing clinical trial pricing aligned with institutional standards

• Experience working with sponsors and internal stakeholders on budget development and contract processes

• Experience with systems such as Excel, eBridge, or financial systems (e.g., Encore)

#LI-FL1

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

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

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The Medical College of Wisconsin (MCW) is an Equal Opportunity Employer. We are committed to fostering an inclusive community of outstanding faculty, staff, and students, as well as ensuring equal educational opportunity, employment, and access to services, programs, and activities, without regard to an individual's race, color, national origin, religion, age, disability, sex, gender identity/expression, sexual orientation, marital status, pregnancy, predisposing genetic characteristic, or military status. Employees, students, applicants or other members of the MCW community (including but not limited to vendors, visitors, and guests) may not be subjected to harassment that is prohibited by law or treated adversely or retaliated against based upon a protected characteristic.