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.
Internal Number: 503032
About Columbia University
Columbia University is one of the world's most important centers of research and at the same time a distinctive and distinguished learning environment for undergraduates and graduate students in many scholarly and professional fields. The University recognizes the importance of its location in New York City and seeks to link its research and teaching to the vast resources of a great metropolis. It seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.