Contracts and Clinical Trials Specialist - E4
Contracts and Clinical Trials Specialist - E4
A bachelor's degree (foreign equivalent or higher) in public health, public administration, contract management, communication, healthcare administration, business administration, business, law or a directly related field from an accredited institution. Demonstrated experience with contract management and/or negotiations, editing legal documents, or similar field of experience. A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis. Demonstrated financial and/or administrative experience.
Significant experience and in-depth knowledge of federal and non-federal regulations and guidelines, cost principles, uniform administrative requirements for grants and audits of states, local governments, and non-profit organizations. Demonstrated independent initiative to interpret and apply applicable regulations, policies, and procedures in a university or an agency funding or conducting research. Demonstrated experience and efficiency in the negotiation of complex research or clinical contracts (such as those involving intellectual property, publication restrictions, export control, data use and data transfer, confidential information and federal FAR clauses) as well as familiarity with federal and non-federal regulations and guidelines. Knowledge of university administrative practices and systems such as pre-awards electronic routing and submission systems, Oracle E-Business Suite, PeopleSoft, and/or Google Apps for Education. Ability to analyze and/or prepare project budgets. J.D. or other advanced degree (or foreign equivalent).
Brief Description of Duties:
The Office of Sponsored Programs is seeking a highly motivated and skilled contracts and clinical trials specialist to join its team to provide comprehensive contract administration for a diverse portfolio of sponsors and partners. The successful candidate will be responsible for comprehensive contract administration including preparation, review and negotiation agreements and contracts, exercising sound decision-making and problem solving skills in the negotiation of contracts (including amendments, modifications, and subcontracts as necessary), and for assisting in the development of administrative procedures to comply with regulations affecting governmental and industry sponsored contracts. The successful candidate will serve as a liaison between Sponsored Programs, Intellectual Property Partners, Research Compliance, Legal Counsel, Sponsor, Principal Investigator, School of Medicine (SOM)/ Office of Clinical Trials (OCT), Central Office of the Research Foundation and post award as necessary to accomplish negotiation and contract administration in a timely manner.
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. 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. Act as University representative to sponsoring agencies and work with outside patent counsel in the process of negotiating agreements. Assist PIs in reviewing budgets for research agreements and act as liaison with Compliance entities.
- 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/clinical trials administration.
- 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. 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.
- Provides coverage and back up administrative support to other members of the team.
- Drafts, compiles and completes various forms, notices, certifications, and other communication, required by sponsors.
- Conducts regular data integrity reviews and resolves discrepancies between contracts, proposals and system data.
- Sharply focuses on continuous improvement of processes and procedures to ensure maximum effectiveness throughout the contract negotiation and with changing business needs. Communicates suggestions for increased efficiencies to senior leadership.
- Other duties as assigned.
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.
This position may be eligible for alternative workplace arrangements/telework (remote or virtual) or hybrid.
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 Office of Equity and Access (OEA) at (631) 632-6280 or visit OEA.
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