Assistant Director Research Administration

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Assistant Director, Research Administration
The candidate will serve as Assistant Director of Clinical Research Administration for the Office of Clinical Research (OCR) reporting to the Director of the OCR, in coordination with the Director of the Division of Sponsored Programs in the UF Office of Research. Responsibility for carrying out the OCR function as it relates to applicable sponsored programs relating to human subjects research or “clinical research”, including Power of Attorney to execute proposals and awards with sponsors, CDA’s, Clinical Trial Agreements, and Master Agreements. Act in accordance with the policies and procedures established by OCR and will ensure that those actions are coordinated with the Directors of OCR and Sponsored Programs and the Office of Technology Licensing (OTL) as it relates to matters of research policy and intellectual property policy, respectively. Responsible for providing guidance and training of the research administration teams with regard to clinical research administration trends and issues. Responsible for the negotiation of grants and contracts with Federal , State, Corporate and other sponsors related to Clinical Research. Make decisions concerning Intellectual Property language and coordinate with the Office of Technology Licensing (OTL), as appropriate. Particularly focus on Pre Award issues and will also be responsible for the negotiation of lower tier sub-awards to sub-recipients or for the establishment of Notices of Award (NOA). Will approve proposals for submission to extramural funding sources and accept grants, contracts and lower tier sub-awards, under a limited power of attorney arrangement granted by the President of the University. Perform these duties in a coordinated effort with others in a way which will enhance the effectiveness of the OCR and the DSP with the faculty and administrators and reflect favorably on the University. Manage the team and processes surrounding the registration of all UF applicable clinical trials (“ACTs”) of drugs, biologics, and devices into Clinical Trials.gov via a web based data entry system, Protocol Registration System (PRS), as required by The Food and Drug Administration Amendments Act of 2007 (FDAAA or US Public Law 110-85) which was passed on September 27, 2007 for results reporting, and any and all registration requirements promulgated by the National Institutes of Health (NIH). Advise all relevant stakeholders as to registration and reporting requirements, if applicable, related to Medicare billing and scientific publications. Will remain current current on all matters related federal regulations pertaining to Clinical Trials.gov and keep apprised of national trends and regulatory changes in this field. Network with other institutions and participate in national events as appropriate and share this knowledge with pertinent UF an OCR stakeholders as appropriate. Perform regular benchmarking with other institutions relative to emerging best practices respecting ClinicalTrials.gov compliance. Will be fully knowledgeable of the methodologies for producing and generating sponsored program award data and will assist the OCR staff with responding to surveys, preparation of data for reports to the Florida Legislature, University Board of Trustees and others as required. Will also generate applicable management reports for OCR/DSP leadership. Will keep abreast of all research administration developments, including Electronic Research Administration, in the external environment so that the impact on the OCR’s stakeholders and University can be assessed and ability to compete for grants. Will keep abreast of all research administration developments, including PeopleSoft and DSP’s UFIRST pre-award platform, in the University environment so that the impact on the OCR can be assessed and ability to manage grants. The Assistant Director will ensure continuous review and improvement of the research administration processes of the OCR in coordination with DSP.

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