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Experience
4 yrs required
Location
New York City, NY, United States
Posted on
Nov 17, 2015
Profile
Senior Contract Specialist
The candidate reports directly to the Manager of Contracts (the Manager) of the Clinical Trials Office (the CTO). Assists the Manager in providing contracts negotiations of clinical trials with Sponsors for the research community at P&S. Assists investigators and academic/research staff in developing clinical trials at P&S and provides administrative resources and infrastructure to build and sustain clinical trials research at P&S. Collaborates with the Manager, the Executive Director of the CTO, General Counsel, P&S faculty and administration and NYPH administration in meeting the institutional needs regarding clinical trial negotiations and execution. Liaises with internal partners in research such as Sponsored Projects Administration, the Institutional Review Boards (the IRB) and the Office of Research Compliance and Training. Negotiates Clinical Trial Agreements directly with the Sponsors according to institutional policies and procedures. Assists the Manager in developing and implementing policies and procedures designed to assure that Clinical Trials Agreements at P&S are carried out in compliance with applicable federal and state regulations, including those promulgated in the US Food and Drug Administration, the US Department of Health and Human Services, the Centers for Medicare and Medicaid Services and the rules of the Joint Commission. Drafts, negotiates and distributes Subcontracts on behalf of the research community. Prepares all Agreements for execution following institutional policies and procedures. Functions as primary contact for the Principal Investigator and designated study team on the progress of contract negotiations. Should have a Bachelor's degree or equivalent in education and experience with 4 years of experience in paralegal profession or J.D. or advance degree may substitute in part for experience. Strong computer skills required, including, Microsoft Office (Word, Excel, PowerPoint).
Company info
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