Senior Contract Specialist

Responsibilities

• Collaborate with the Director, the Executive Director of the CTO, General Counsel, VP&S faculty and administration, and 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.
• Affiliate with 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.

Qualifications

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