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CLASSIFICATION TITLE:
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Assistant Director of Clinical Research Administration
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JOB DESCRIPTION:
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Serves 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. The Assistant Director has day-to-day 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. The Assistant Director will 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. The Assistant Director
is also responsible for providing guidance and training of the research administration teams with regard to clinical research administration trends and issues. Essential functions of this position include:
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The Assistant Director will be responsible for the negotiation of grants and contracts with Federal , State, Corporate and other sponsors related to Clinical Research. The Assistant Director will
make decisions concerning Intellectual Property language and coordinate with the Office of Technology Licensing (OTL), as appropriate. The Assistant Director will 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).
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The Assistant Director 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. The Assistant Director will 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.
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Regulatory - The Assistant Director will 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. In addition, they 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
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Reports and Data Management - The Assistant Director 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 of Florida Board of Trustees and others as required. As requested, the Assistant Director will also generate applicable management reports for OCR/DSP leadership.
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The Assistant Director 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 our ability to compete for grants and contracts is not compromised. The Assistant Director 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 our ability to manage grants and contracts is not adversely affected. 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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ADVERTISED SALARY:
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Commensurate with education and experience.
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MINIMUM REQUIREMENTS:
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Master’s degree in an appropriate area of specialization and two years of appropriate experience; or a bachelor’s degree in an appropriate area of specialization
and four years of appropriate experience.
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PREFERRED QUALIFICATIONS:
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Advanced Degree (JD, PhD or Masters) and 5 years’ experience in sponsored programs administration or Bachelor’s degree and 7 years sponsored programs administration experience; strong administrative,
negotiating and communication skills; positive leadership qualities.
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Three or more years of experience in sponsored programs contract negotiation and outgoing Subaward/subcontract administration; a demonstrated knowledge of federal policies governing the administration
of Subawards, grants, cooperative agreements, and contracts at educational institutions, including the relevant Federal Acquisition Regulations, Code of Federal Regulations (including 2 CFR 200), and sponsor policy requirements.
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Demonstrated oral and written communication skills required. Ability to negotiate solutions to complicated situations involving prioritization of competing requests of many parties, to independently
interpret and develop effective policies and procedures, and to communicate effectively with contract officers, staff, and faculty..
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An understanding and awareness of federal initiatives, changes to regulations and evolving national trends that affect sponsored program administration at educational institutions, such as the Federal
Demonstration Partnership, changes to the Final Rule, NSF Fastlane and the NIH Commons.
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Knowledge and experience with developing, negotiating and administering federal awards, non-federal contracts, grants, and cooperative agreements. Experience in Subaward administration is highly
desirable.
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Ability to exercise good judgment; deal with ambiguity, analyze complex situations, identify workable solutions, alternatives and exceptions in support of making determinations and/or recommendations
that balance efficiency and risk mitigation to UF. Ability to determining when and who to escalate/ adjudicate complicated and/or sensitive matters.
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Ability to balance customer service with regulatory compliance.;
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Ability to organize and work effectively, prioritize and be flexible in a high-paced, high-volume professional environment, and to conduct negotiations and execute awards in a timely manner.;
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Ability to develop and maintain effective working relationships in a diverse and multilayered environment.;
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Demonstrated ability to train effectively on a 1:1 and group basis;
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Ability to work effectively in a team environment, consulting with appropriate parties as needed. Willingness to learn new things and to take on special projects or additional duties as needed;
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SPECIAL INSTRUCTIONS TO APPLICANTS:
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To be considered for this position all applicants must submit a cover letter, resume and list of references.
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This position requires a background check.
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Application must be submitted by 11:55 p.m. (EDT) of the posting end date.
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HEALTH ASSESSMENT REQUIRED:
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No.
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