Senior Contract Specialist

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 the 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 VP&S and provides administrative resources and infrastructure to build and sustain clinical trials and clinical 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:

• Collaborate with the Director, the Executive Director of the CTO, General Counsel, VP&S faculty and administration, and New York-Presbyterian Hospital (“NYPH”) administration to meet 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.
• Liaise with internal departments such as Sponsored Projects Administration, Columbia Technology Ventures, Institutional Review Boards (IRB), Procurement, and the Office of Research Compliance and Training.
• Negotiate Clinical Trial Agreements (CTAs) with sponsors, ensuring alignment with budgetary considerations and institutional policies and procedures.
• Assist the Director in the development and implementation of policies and procedures that ensure Clinical Trial Agreements comply with applicable federal and state regulations, including those promulgated from 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 Joint Commission.
• Draft, negotiate, and distribute subcontracts on behalf of the research community.
• Prepare agreements for execution in accordance with institutional policies and procedures.
• Maintain and update activity databases and workflow trackers.
• Collaborate with pre-award, post-award, and regulatory colleagues within the CTO to provide seamless support to the research community.
• Serve as the primary point of contact for Principal Investigators and study teams regarding the status of contract negotiations.
• Performs related duties & responsibilities as assigned/requested.

Minimum Qualifications

• Juris Doctor (J.D.) degree with at least 3 years of experience in a related field.

Preferred Qualifications

• 3+ years of experience in contract negotiation and administration, with a solid understanding of contracting principles, risk management, and their application to clinical research and clinical research lifecycle.
• Demonstrated ability to work independently, with prior project management experience.
• Strong 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.