New England HERC

• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Salary Range: $95,000 - $110,000

Position Summary

Reporting directly to the Associate Director of Contracts (the ???Director???) of the Clinical Trials Office (the ???CTO???) of Columbia University???s Vagelos College of Physicians & Surgeons (???VP&S???). The Senior Contract Specialist will administer agreements (such as clinical trials, research services, and confidentiality agreements) from inception through termination, which includes, but is not limited to, negotiation, providing consultation/advice, which will best meet the needs of, research community at VP&S. One of the main objectives of this position is to have the necessary skill set to support the contracting processes.

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 VP&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

Responsibilities include, but not limited to the following:

•  Collaborates with the Associate Director, the Associate Vice President of the CTO, General Counsel, VP&S faculty and administration and NYPH administration in meeting the institutional needs regarding clinical trial negotiations and execution. The role of the Contract Specialist includes being skilled and qualified to negotiate and develop contracts using knowledge of applicable Institutional policies and procedures, as well as various laws, statutes, guidelines and requirements.

• Liaises with internal partners in research such as Sponsored Projects Administration, Columbia Technology Ventures, the Institutional Review Boards (the ???IRB???), Procurement and the Office of Research Compliance and Training.
• Negotiates Clinical Trial Agreements including budgetary considerations directly with the Sponsors according to institutional policies and procedures.
• Assists the Associate 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.
• Update & maintain all activity on current databases & workflow trackers.
• Collaborates with pre-award/post-award colleagues, and regulatory units in the CTO to provide seamless services for the research community.
• Functions as primary contact for the Principal Investigator and his/her designated study team on the progress of his/her contract negotiations.

Minimum Qualifications

• Bachelor???s Degree with at least 3 years of related experience in a related field; or paralegal or Juris Doctorate (J.D.) degree.

Preferred Qualifications

• Three years of contract negotiation experience negotiating and administering public or private contracts, with a solid understanding of contracting principles, risk management and how they are applied to clinical research agreements and clinical trials as a whole.
• 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 (Outlook, Word, Excel, PowerPoint, SharePoint), DocuSign, AdobeSign, Teams, Zoom

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.

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.

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