Contracts and Clinical Trials Specialist - E4

New York, United States
Salary Not specified
Nov 25, 2020
Employment Level
Employment Type
Full Time

Contracts and Clinical Trials Specialist - E4

Required Qualifications:

Bachelor's Degree (foreign equivalent or higher). In lieu of a Bachelor's Degree, an Associate Degree and two (2) years of full-time experience involving research grants, subawards and/or contracts in a research setting may be considered. Experience negotiating and/or administering a variety of research awards. One (1) year of 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:

Three (3) years of full time experience in the pre-award area. Experience in clinical observational and interventional research administration. Experience with Huron/myResearch or other pre-awards electronic routing and submission system. Knowledge of Clinical Conductor, Oracle E-Business Suite (PIAI, MAS and MPSA Reports), 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. Ability to analyze and prepare project budgets.

Brief Description of Duties:

Contracts and Clinical Trials Specialists work within the scope of contracts and protocols to prepare, distribute, track and file contracts and clinical trials documents. Due to legal and ethical issues, they must adhere to stringent guidelines to make sure that contracts and trials are credible, and subjects are protected. The successful incumbent must have outstanding written, verbal, and interpersonal communication skills. Experience successfully working independently as well as part of a team with a collaborative approach to problem solving. Experience effectively multi-tasking in a fast-paced, deadline driven environment with a high degree of accuracy and organization. Strong organizational and time management skills with exceptional attention to detail. Must possess ability to thrive in a busy, high-volume, and deadline driven work team environment that requires coordination of multiple activities and the judgment and flexibility to reprioritize to accommodate emergency requests. Experience interacting with individuals at various levels within an institution as well as the general public whenever necessary. Ability to speak confidently when communicating with investigators and industry professionals.

  • Responsible for drafting, negotiating, recommending acceptance and administering of research, testing, lab study agreements, including sponsor or investigator-initiated clinical trials, supported by a variety of sponsors. These sponsors include local, federal, national, international, private, non-profit, public and for profit organizations with particular emphasis on the pharmaceutical industry. 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 (ex: 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.

  • 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

  • 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. FLSA Exempt position, not eligible for the overtime provisions of the FLSA. Minimum salary threshold must be met to maintain FLSA exemption.

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).

Resume/CV and cover letter should be included with the online application.

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.

If you need a disability-related accommodation, please call the university The Office of Equity and Access (OEA) at (631) 632-6280 or visit OEA.

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