Assistant Director

The mission of the Office of Clinical Research (OCR) is to provide faculty with resources, information and expertise in clinical research to advance the science of healthcare. The OCR facilitates the process of conducting clinical research, from inception through completion, with the ultimate goal of delivering state of the art healthcare services to the community in the Greater Tampa Bay area and beyond. We are committed to streamlining procedures and enhancing services for clinical investigators and research staff, affiliate partners, extramural sponsors and research volunteers. The strategic services, education and training, and comprehensive review processes provided by the OCR are designed to foster research teams who are benchmarking the next generation standard of care. As part of the integration plan for the TGH and USF Offices of Clinical Research, an Assistant Director level position is requested to provide oversight in the Joint Research Office as well as the USF office. The Assistant Director of Clinical Trial Management Systems will have oversight of the clinical trial management systems at both Institutions to provide consistency in processes, improve data tracking and reporting, and improve efficiency and customer service overall. The Assistant Director will have an employee agreement executed with Tampa General Hospital.

Minimum Qualifications:

Bachelor's Degree, Master's preferred. 7 or more years' experience with CTMS implementation. 5 years managerial experience

Preferred Qualifications:

Minimum of seven years related experience in CTMS implementation, including five years managerial experience. This position requires a seasoned leader with specific expertise and experience in the area of implementation and oversight of clinical trial management systems. It requires extensive problem solving skills; is given full authority to make critical decisions on the daily operation of the business unit; is expected to provide decision support advice to the senior leadership in USF Health as well as our hospital partner, Tampa General hospital; works directly with unit and department heads on behalf of the Office of Clinical Research. This is a leadership position that reports directly to the Executive Director in USF Health and Morsani College of Medicine. SB 1310: Substitution of Work Experience for Postsecondary Education Requirements A public employer may include a postsecondary degree as a baseline requirement only as an alternative to the number of years of direct experience required, not to exceed: (a) Two years of direct experience for an associate degree; (b) Four years of direct experience for a bachelor's degree; (c) Six years of direct experience for a master's degree; (d) Seven years of direct experience for a professional degree; or (e) Nine years of direct experience for a doctoral degree Related work experience may not substitute for any required licensure, certification, or registration required for the position of employment as established by the public employer and indicated in the advertised description of the position of employment. Minimum Qualifications that require a high school diploma are exempt from SB 1310. Responsible for the implementation and daily operations of clinical trial management systems, focused on managing all aspects of these enterprise-wide systems, including oversight of the technology vendors. Oversight of study design and management of clinical trial agreements and amendments in the clinical trial management systems. Study design encompasses analyzing and interpreting protocols, calendar/timeline building, budgets, adjusting study builds to reflect contractual amendments. Responsible for coordinating technical integration implementation efforts, helping to establish goals and objectives, manage and meet the expectations of the program, and manage the scope and timeline associated with the technical integration initiatives. Oversight of initial and continued end-user training of clinical trial management systems, including the development of training manuals, user guides, and tip sheets. Maintain user access and oversight of security and compliance of all end-users. Oversight of clinical research reporting generated from the clinical trial management systems. Reporting provided to the key stakeholders such as the Executive Director, AVP and departmental chairs for strategic planning, budget management, and evaluation of MCOM and TGH's clinical research programs at the service line, department and college level. Reviews and updates the processes and procedures for the office as related to area of oversight. In addition, this position will develop processes and procedures working with our affiliate partner, Tampa General Hospital, to provide consistency in processes and increased efficiency.