Senior Contracts & Clinical Trials Officer

Senior Contracts & Clinical Trials Officer Required Qualifications 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. At least 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 system. 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 terms and conditions of research grants or contracts, as well as post award administration. Experience in clinical trials contracts negotiations. Brief Description of Duties Draft, negotiate, recommend acceptance and administer research, testing, lab study agreements, including sponsor or investigator-initiated clinical trials, supported by a variety of sponsors. Act as University representative to sponsoring agencies and work with outside patent counsel in the process of negotiating agreements. Assist PIs in formulating budgets for investigator-initiated clinical trials or other research agreements and act as liaison with Compliance entities. Provide liaison between and among faculty and corporate sponsors, campus administrative offices and the School of Medicine (SOM)/ Office of Clinical Trials (OCT) and Central Office of the Research Foundation. Work closely with OCT and other areas within SOM on understanding the function as well as maintaining existing clinical trials management systems (e.g. Clinical Conductor, OnCore) and play a decision-making role in any future related implementations. In collaboration with OCT, Offices of Compliance and Grants Management and the team of contract administrators within OSP that oversee the clinical research activities, develop effective and skillful practices related to 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 senior member of the contracts team by being a problem‑solving business partner to the Assistant Director for Contracts. Contribute to the achievement of contract unit goals and its operating plans with direct impact on the results. Develop and apply solutions to unusually complex problems which require the regular use of a high degree of ingenuity, creativity, and innovation. Mentor new and junior contracts and clinical trials negotiators, and update established efficient processes or develop new procedures to reduce cycle time, and timely execution of contracts. Work towards making moderate to substantial improvement or enhancements to systems and processes to improve performance of the contracts area. Authorize the establishment of accounts and fiscal transactions pertaining to the establishment of awards, the advancing of funds, increases to account budgets and extension of term dates with and without funding, with particular 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. Maintenance of a database consisting of all sponsored clinical research initiatives. Represent Office of Sponsored Programs at campus and external meetings. Provide clinical research presentations and informational sessions to the campus community. Special projects as assigned. Act as back‑up for the team of contracts administrators in OSP as needed. Collaborate with OR&I and SOM to develop a clinical trial contracting group that will expand operations. Other duties as assigned. Special Notes The Research Foundation of SUNY is a private educational corporation. Employment is subject to the Research Foundation policies and procedures, sponsor guidelines and the availability of funding. This is a full‑time appointment. FLSA Exempt position, not eligible for the overtime provisions of the FLSA. Minimum salary threshold must be met to maintain FLSA exemption. For this position, we are unable to sponsor candidates for work visas. Due to U.S. Export Control laws and regulations, the candidate hired will need to be a U.S. citizen, lawful permanent resident, or other "protected individual" (as defined by 8 U.S.C. Sec. 1324b(a)(3)). Equal Opportunity Employer 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. Salary and Benefits The starting salary range (or hiring range) to be offered for this position is noted below, it represents SBU’s good faith and reasonable estimate of the range of possible compensation at the time of posting. #J-18808-Ljbffr Stony Brook University