MGR, Clinical Research at InsideHigherEd

MGR, Clinical ResearchJob No: 538035Work Type: Full TimeLocation: Main Campus (Gainesville, FL)Categories: Health Care Administration/SupportDepartment: 29050800 - MD-INFECTIOUS DISEASESJob Description Classification Title: Manager, Clinical ResearchJob Description: Under the direction of the Assistant Director, the Manager, Clinical Research will be responsible for providing management and direction of the division's clinical and human subject research portfolio. This position will be responsible for managing all budgetary and fiscal matters related to clinical trials, including negotiating clinical trial budgets and payment terms with industry sponsors, managing all post award financials, invoices, and reconciliations. This position will oversee the team of coordinators to ensure they have all necessary resources to perform their jobs effectively and efficiently. Pre-Award Clinical Trial Management Lead clinical trial negotiations with industry sponsors, with support from the Principal Investigator and Assistant Director and assistance from clinical research coordinators. Oversee the preparation of IRB applications and maintain regulatory and IRB approvals throughout the project lifecycle and serve as a resource for the clinical research coordinators during their completion of the IRB process Prepare financial analysis for proposed clinical trials to ensure financial viability of study based on enrollment projections Review clinical research protocols to assess feasibility and serve as a resource, providing guidance, to study coordinators with planning and implementing strategies for successful participant recruitment. Managing all clinical trial workflow through UFIRSTPost Award Clinical Trial Management Maintain accurate accounts receivable and payable data Invoice sponsors for services rendered Reconcile all electronic study payments via the university's clinical research system Prepare monthly reports outlining financial status of studies, enrollment target, etc. and present to PI and Assistant Director Facilitate timely reconciliation and close-out of terminated clinical trial accounts Maintain, oversee, reconcile, and correct errors in accounts. Process clinical research and core bills for payment Partner with Clinical Trial team on budgetary amendment implementation Manage clinical study financial closeout and residual balance transfers Oversee updates to documentation in response to IRB or Regulatory comments and queries, ensuring all regulatory documents are current and compliant, in conjunction with the clinical research coordinators Oversee the preparation and collation of all documentation required to support clinical trial applications, ensuring compliance with regulatory standards. Direct the development and review of briefing documents to facilitate effective meetings with regulatory bodies Coordinate the preparation and submission of annual reports, ensuring timely and accurate documentation. Implement and maintain a comprehensive document filing system for easy access and historical tracking of documentation across projects Supervise the renewal, re-registration, and submission of variations, amendments, and notifications, maintaining up-to-date regulatory status reports for all active projectsTeam Management Function independently and proactively with strong critical thinking, analytical, and communication skills Support the Chief, Faculty, and Division Administrator in advancing the research missions of the Division of Infectious Diseases and Global Medicine. Collaborate closely with clinical research coordinators, the grants team, the Division Administrator, and the University's clinical research hub to oversee the division's clinical research activities. Provide training and support to divisional clinical research coordinators and serve as a clinical research coordinator for select clinical trials. Step in as a study coordinator as needed to support ongoing clinical trials and ensure continuity of research activities. Oversee the clinical research team staffing, working closely with clinical research coordinator 3's to ensure the team is sufficiently and appropriately staffedOther Assist the Division Administrator with ad hoc assignments to support basic science research faculty and laboratories. Prepare annual budget information to include in the division's annual budget. Manage the division's clinical trials operating account, including preparing annual projections for daily management and future staffing purposes.Expected Salary: $82,000 - 92,200 annuallyRequired Qualifications: Master's degree in appropriate area of specialization; or a bachelor's degree in appropriate areas of specialization and two years of experience.Preferred: Prior experience negotiating clinical trials with industry sponsors.Familiarity with regulatory documentation and clinical trials.Prior clinical trial coordinator experience.Strong communication skills, good organization, detail oriented, familiarity with medical environment.Special Instructions to Applicants: In order to be considered, you must upload your cover letter and resume. Application must be submitted by 11:55 p.m. (ET) of the posting end date.Health Assessment Required: Yes Applications Close: 17 December 2025To apply, visit https://explore.jobs.ufl.edu/en-us/job/538035Our Commitment:The University of Florida is an Equal Employment Opportunity Employer.Hiring is contingent on eligibility to work in the U.S. The University of Florida is a public institution and is subject to all requirements under Florida Sunshine and Public Record laws. If an accommodation due to a disability is needed to apply for this position, please call 352-392- 2477 or the Florida Relay System at 800-955-8771 (TDD) or visit Accessibility at UF.Copyright ©2025 Jobelephant.com Inc. All rights reserved.Posted by the FREE value-added recruitment advertising agency jeid-174f5917a2982e4dac21891c10215c90