Reporting to the AVP of the Clinical Trials Office (the ???CTO???) of Columbia University???s Vagelos College of Physicians & Surgeons (???VP&S???) at Columbia University Irving Medical Center (???CUIMC???), the Associate Director of Contract Negotiations is responsible for the management and oversight of all negotiations and execution of contracts in the CTO.
The CTO, which is operated jointly with the New York-Presbyterian Hospital (???NYPH???), assists investigators and academic/research staff in developing clinical trials and provides administrative resources and infrastructure to build and sustain clinical trials research at VP&S.
The Responsibilities of the Associate Director include, but are not limited to
Collaborates with the AVP of the CTO, the Directors of the CTO, Columbia University faculty and administration and NYPH administration in meeting the institutional needs for clinical trials contract and budget negotiations.
Manages a team of Contract Specialists in the CTO, including all negotiation processes, providing training, guidance, and administrative oversight.
Oversees the contract operations of the CTO, including the negotiation of contracts for industry-sponsored trials.
Oversees the contractual negotiations of government and foundation sponsored clinical trials.
Serves as the primary liaison with NYPH with respect to contract and negotiation matters.
Ensures compliance with government and University rules and regulations relating to the contractual and budgetary aspects of conducting clinical trials.
With the AVP of the CTO, establishes strategic contract, budget and recruitment goals and develops plans to meet milestones.
Collaborates with the Directors of the CTO, the CTO staff and investigators in assessing the regulatory and contractual risks of proposed clinical trials.
Develops and implements contract and negotiation policies and procedures within the CTO.
Collaborates with Columbia University???s Office of General Counsel to ensure research agreement compliance with University statutes and Office of General Counsel policies.
Summarizes, interprets and reports on the contractual aspects of the CTO.
Provides training and guidance to contract negotiators in other offices in the institution, including, Institutional Review Board (IRB) and Sponsored Projects Administration (SPA).
Liaises and coordinates with collaborators from central administration, such as Columbia Technology Ventures (CTV) for effective contract negotiations.
Provide support to initiatives in the Office of the Executive Vice President for Research.
Liaises with Investigators, research teams, and administrators to provide guidance on rules and regulations, as well as contractual aspects.
Degree requirement: Doctor of Jurisprudence
At least 5 years of experience in contract negotiation.
In-depth knowledge of the contractual aspects of clinical research.
Demonstrable ability to collaborate with partners in research (including government, foundation and industry sponsors), investigators and research staff.
Knowledge of clinical trials, research protocols, Good Clinical Practice.
Expert knowledge in NYS Law regarding research, FDA and other regulatory agencies.
Excellent verbal and written communication skills.
Excellent interpersonal and presentation skills.
Type preferred qualifications
Type other requirements and/or special indicators if CUIMC
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 516376
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