Clinical Trials Budget Specialist II - Office of Research
The Medical College of Wisconsin, Inc.
Job Description
<h3><u><b>Summary</b></u></h3><p>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. </p><p>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. </p><p>This position is fully remote, and all remote work must be performed within one of the MCW registered payroll states, which currently includes: WI, AZ, FL, IL, IN, MD, MI, MN, MO, NC, TN,TX, UT, GA, and DE.</p><h3><u><b>Primary Responsibilities </b></u></h3><ul><li><p>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. </p></li><li><p>Work in collaboration with ancillary teams, departments, investigators, research staff, supporting administration, and sponsors/funding agencies to create complete, comprehensive, accurate and timely budgets. </p></li><li><p>Ensure appropriate research rates are applied to study budgets.</p></li><li><p>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. </p></li><li><p>Submit and maintain the budget and other financial information into OnCore Clinical Trial Management System (CTMS) to maintain proper reimbursement and revenue integrity.</p></li><li><p>Perform pre-award quality assurance to verify completion of required elements prior to Medicare Coverage Analysis. </p></li><li><p>Communicate and meet with stakeholders to facilitate ongoing budget discussions and provide updates to relevant parties.</p></li><li><p>Use advancing knowledge to develop and disseminate clinical research education as needed in accordance with federal regulations, institutional policies, and specific protocol requirements.</p></li><li><p>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.</p></li><li><p>Develop and support the formulation of program policies, procedures, and resources to establish and enhance clinical