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This position serves as the Administrative Director of the Institutional Review Board (03) at the University of Florida Health Science Center, Jacksonville (UFHSCJ). This Institutional Review Board (IRB) is composed of a group of scientists and others who review biomedical research under the rules and regulations of the FDA, NIH/OPRR that safeguard the rights and welfare of human subjects. This position is responsible for administering the UFHSCJ’s compliance with these rules and regulations and facilitating the participation of faculty in such research. This position reports administratively to the Assistant Dean, Research Administration and Compliance at the College of Medicine, Jacksonville.
ESSENTIAL FUNCTIONS OF THE JOB
Ensures fully documented compliance with all applicable rules and regulations. This includes obtaining, disseminating and maintaining all applicable federal, state and institutional rules and regulations. Develops and maintains IRB procedures in compliance with all such guidelines. Serves as a primary contact for Federal Auditors and informs the appropriate university officials of such visitors or planned visits.
Develops, plans, and helps implement programs to inform investigators and IRB members of the required procedures and formats for research proposals that involve human subjects. This involves, new IRB members as well as new faculty and medical residents involved in human subject research. Provides campus training on the UF IRB process.
Coordinate with senior core office administrators, core office staff and Board members, if applicable, to assist with the processing and review of protocols.
Represent the research compliance office in meetings and committees in support of research compliance processes at the University.
May prepare and edit core compliance office publications.
Solicit input from compliance board members and Principal Investigators to improve services and educational opportunities.
Assist in implementing program changes.
Work with the Assistant Director of IRBs in Gainesville to ensure compliance with all applicable rules and regulations, develops and maintains procedures in compliance of such guidelines; prepare documents that are required by federal and state compliance agencies.
Assists with investigator protocol development, including regulatory review
Assists in the preparation of and administers operating budget.
Assists in the maintenance of the current computerized database and facilitates with the upgrade of the database and computer systems in the office. Responsible for records maintenance (including agendas, minutes, research protocol files) and retrieval. Responsible for ensuring that IRB records reflect verifiable compliance with all applicable guidelines.
Manages communication with the WIRB for specified research protocols at the UFHSCJ. This involves the monthly file maintenance on this campus for the linkage between the two IRB offices in order to ensure compliance with the necessary regulations.
Auditing and compliance – active surveillance of research record keeping to ensure compliance with what has been approved by the IRB and compliance with federal regulations
Supervise professional and other core compliance office staff.
Responsible for all IRB –03 Board Meetings, i.e. pre and post meeting activities including serving as secretary for all meetings.
He/she must possess superior communication and presentation skills and the ability to foster positive relations with multiple, diverse constituencies to influence and shape change. Strong customer focus (ability to listen attentively to residents/fellows and faculty and to understand and respond positively to their requests) required. Ability to work under pressure, with the flexibility to respond to changing priorities and fluctuating workloads.
POLICY MAKING AND/OR INTERPRETATION.
Will assist in developing UFHSCJ policies and procedures to ensure documented compliance with FDA, NIH and other applicable rules and regulations. Serves as a resource to the UFHSCJ faculty and staff in the interpretation of all rules and regulations regarding human subject research. Assist in developing policies and procedures to ensure UF’s documental compliance with all applicable rules and regulations.
Serves as a resource to the University community in the interpretation of all applicable rules and regulations.
Will serve as a liaison between the UFHSCJ IRB03 and Federal and State agencies to stay in compliance with necessary regulations governing research using human subjects. Will interact daily with UFHSCJ faculty and staff. Will attend all IRB –03 meetings and serve as secretary. Will communicate regularly with the IRB-01 office.
Master’s Degree in an appropriate area of specialization or equivalent experience, or a bachelor’s degree and two years of experience in the administration of an Institutional Review Board. The employee must have managerial experience in order to be effective in the performance of these job duties. Must also possess outstanding written, oral, interpersonal and organizational skills. Familiarity with PC applications, medical terminology, research design, statistics and academic and regulatory functions. Dedication to providing service. Physical ability to move large bundles of paper and heavy boxes of paper.
The University of Florida is a comprehensive learning institution built on a land grant foundation. We are The Gator Nation, a diverse community dedicated to excellence in education and research. University of Florida, the state's oldest university, traces its beginnings to 1853. Today, the university has more than 50,000 students and 16 colleges. UF has a 2,000-acre campus and more than 900 build...ings on the main campus. Since 1985, UF has been a member of the Association of American Universities, which includes the top 62 public and private institutions in North America. UF is consistently ranked among the nation s top universities: No. 14 in U.S. News & World Report Top Public Universities (September 2015).UF is one of only six universities in the country with colleges of medicine, engineering, law, agriculture and veterinary medicine on the same campus. UF in 2016 opened the UF Innovation Station in Sarasota County, the first physical extension of UF's Florida Engineering Experiment Station (FLEXStation), affording businesses and entrepreneurs unprecedented access to tech workforce talent, applied research, faculty and intellectual property.UF has 36 Eminent Scholar chairs and over 41 faculty elections to the National Academy of Sciences, Engineering, the Institute of Medicine, or the American Academy of Arts and Sciences. More than half of all undergraduate students who start at UF graduate with no student-loan debt.The University of Florida is proud to serve veterans by providing a Collegiate Veterans Success Center, serving as a host site for the U.S. Department of Veterans Affairs' VetSuccess On Campus Program, housing a registered student organization - the Collegiate Veterans Society, and having an Office of Veterans Services.