Reporting directly to the Associate Director of Contracts (the "Associate 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 Manager 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 requirements and institutional policies and procedures.
Responsibilities include, but not limited to the following:
1.Collaborates with the Associate 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.
2.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.
3.Negotiates Clinical Trial Agreements directly with the Sponsors according to institutional policies and procedures.
4.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 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.
5.Drafts, negotiates and distributes Subcontracts on behalf of the research community.
6.Prepares all Agreements for execution following institutional policies and procedures.
7.Functions as primary contact for the Principal Investigator and his/her designated study team on the progress of his/her contract negotiations.
Other duties as assigned. Minimum Qualifications for Grade
Applicant MUST meet these minimum qualifications to be considered an applicant Bachelor's Degree or equivalent in education and experience with four years experience in paralegal profession or Juris Doctorate (J.D.) or advance degree may substitute in part for experience. Additional Position-Specific Minimum Qualifications
Applicant MUST meet these minimum qualifications to be considered an applicant The candidate must be able to work independently with prior project management experience.Excellent verbal and written communication skills. Excellent interpersonal and presentation skills.
Strong computer skills required, including, Microsoft Office (Word, Excel, PowerPoint). Special Instructions Preferred Qualifications Juris Doctorate (J.D.) or advance degree highly preferred. Essential Functions Additional Essential Functions (Limit to 3950 characters.) Special Indications
This position works with: There are no special indications for this position