Senior Contracts & Clinical Trials Officer

This is a full-time, FLSA exempt position with the Research Foundation of SUNY, subject to Research Foundation policies and sponsor guidelines. U.S. citizenship, lawful permanent residency, or other protected individual status is required due to U.S. Export Control laws.

About the Role

This role involves drafting, negotiating, and managing research contracts, including clinical trial agreements, testing and laboratory study agreements, research collaborations, and industry-sponsored contracts. The specialist ensures compliance with university policies and federal/state regulations while liaising with faculty, sponsors, and administrative offices to streamline contract execution. The Senior Contracts and Clinical Trials Specialist works within the scope of contracts and protocols to prepare, distribute, track, and file contracts and clinical trials documents, adhering to stringent guidelines to ensure credibility and protection of subjects.

The successful candidate must thrive in a busy, high-volume, deadline-driven environment, demonstrating exceptional organizational, time management, and multitasking skills with a high degree of accuracy. Strong written, verbal, and interpersonal communication skills are essential, along with the ability to work independently and collaboratively to solve problems.

Responsibilities

• Draft, negotiate, recommend acceptance, and administer research agreements, including sponsor or investigator-initiated clinical trials, supported by local, federal, national, international, private, non-profit, public, and for-profit organizations, with emphasis on the pharmaceutical industry.
• Act as University representative to sponsoring agencies and work with outside patent counsel in negotiating agreements.
• Assist Principal Investigators (PIs) in formulating budgets for investigator-initiated clinical trials or other research agreements and act as liaison with Compliance entities.
• Provide liaison between faculty, corporate sponsors, campus administrative offices, the School of Medicine (SOM), Office of Clinical Trials (OCT), and the Central Office of the Research Foundation.
• Work closely with OCT and other SOM areas to understand and maintain clinical trials management systems (e.g., Clinical Conductor, OnCore) and play a decision-making role in future implementations.
• Collaborate with OCT, Offices of Compliance and Grants Management, and the team of contract administrators to develop effective practices for clinical trials management.
• Provide assistance in contract proposal development, fiscal planning and management, and patent and licensing issues.
• Advise faculty and staff on all facets of grant and contract administration, with particular emphasis on clinical research accounts.
• Serve as primary expert in providing risk assessments and offering alternative approaches to mitigate risks, including alternative contractual language.
• Serve as a senior member of the contracts team and a problem-solving business partner to the Assistant Director for Contracts.
• Contribute to the achievement of contract unit goals and operating plans with direct impact on results.
• Mentor new and junior contracts and clinical trials negotiators, and update or develop efficient processes to reduce cycle time and ensure timely execution of contracts.
• Work toward making moderate to substantial improvements or enhancements to systems and processes to improve contract area performance.
• Authorize the establishment of accounts and fiscal transactions related to awards, advancing funds, budget increases, and term date extensions, with emphasis on clinical research accounts.
• Provide post-award administrative support, including expenditure approvals, accounting detail, and reporting requirement information.
• Monitor the acceptance of costs on contracts, submission of progress reports, and review and approve closeout documents.
• Forge Master Clinical Trial agreements for Stony Brook University and the entire SUNY system.
• Track research projects/agreements and collect data for internal and external purposes.
• Maintain a database of all sponsored clinical research initiatives.
• Represent the Office of Sponsored Programs at campus and external meetings.
• Provide clinical research presentations and informational sessions to the campus community.
• Act as backup for the team of contracts administrators in the Office of Sponsored Programs (OSP) as needed.
• Collaborate with the Office of Research and Innovation (OR&I) and SOM to develop a clinical trial contracting group that will expand operations.
• Perform special projects and other duties as assigned.

Requirements

• Bachelor’s degree (foreign equivalent or higher). In lieu of a Bachelor’s degree, an Associate’s degree and two (2) years of full-time experience involving research grants, subawards, and/or contracts in a research setting may be considered.
• Three (3) years of full-time experience negotiating and/or administering a variety of research awards.
• One (1) year of full-time experience involving research grants, subawards, and/or contracts in a research setting.
• Demonstrated knowledge of federal, state, university, and industry rules and regulations governing technical aspects of grants and contracts.

Preferred Qualifications

• Juris Doctor (or foreign equivalent).
• Two (2) additional years of full-time experience in a pre-award area.
• Experience in clinical observational and interventional research administration.
• Experience with Huron/myResearch or other pre-awards electronic routing and submission systems.
• Experience working with Clinical Conductor, Oracle E-Business Suite RF Report Center, PeopleSoft, and/or Google Apps for Education.
• Experience with industry, private, and government contracting.
• Experience in negotiating the terms and conditions of research grants or contracts, as well as post-award administration.
• Experience in clinical trials contracts negotiations.

Benefits

Stony Brook University is committed to excellence in diversity and the creation of an inclusive learning and working environment. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status, and all other protected classes under federal or state laws.

Pay

The starting salary range for this position is $110,000 - $125,000.