* Requisition no: 503032 * Work type: Full Time * Location: Medical Center * School/Department: Clinical Trials Office * Grade: Grade 104 * Categories: General Administration * Job Type: Officer of Administration * Regular/Temporary: Regular * Hours Per Week: 35
Reporting directly to the Director of Contracts (the \"Director\") of the Clinical Trials Office (the \"CTO\") of Columbia University's College of Physicians & Surgeons (\"P&S\") at Columbia University Medical Center (\"CUMC\"), the Contracts Negotiation Specialist assists the Director in providing contracts negotiations of clinical trials with Sponsors for the research community at P&S.
The CTO 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.
The successful candidate will work with Sponsors in negotiating contracts for clinical trials in accordance with all applicable Regulatory and Legal requirements and institutional Policies and Procedures.
Responsibilities include, but not limited to the following:
* Collaborates with the Director, 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 Director 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 U.S. Food and Drug Administration, the U.S. 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 his/her designated study team on the progress of his/her contract negotiations.
* Minimum: Bachelor's Degree or equivalent in education and experience plus 3 years experience in paralegal profession or Juris Doctorate (J.D.) degree * The candidate must be able to work independently with prior project management experience. * Excellent verbal and written communication skills * Strong computer skills required, including, Microsoft Office (Word, Excel, PowerPoint) * Excellent interpersonal and presentation skills
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Applications open: Sep 16 2019 Eastern Daylight Time Applications close:
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* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.