Sr. Contracts and Clinical Trials Specialist
Sr. Contracts and Clinical Trials Specialist
Required Qualifications (as evidenced by an attached resume):
Bachelor's Degree (foreign equivalent or higher) in legal studies, healthcare administration, business administration, or a related field. Three (3) years of full-time experience involving reviewing, editing, negotiation and/or administration of a variety of research contracts and/or clinical trials. Demonstrated knowledge of federal, state, University/medical center and industry rules and regulations governing technical aspects of grants, contracts and/or clinical trials.
Master's Degree (foreign equivalent or higher) in a related field. Five (5) years of full time experience involving reviewing, editing, negotiation and/or administration of a variety of research contracts and/or clinical trials. Experience with Huron/myResearch or other pre-awards electronic routing and submission system. Knowledge of Clinical Conductor, OnCore, 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 contracts or clinical trials, as well as post award administration.
The Sr. Contracts and Clinical Trials Specialist will play an essential role in the clinical trial process. Working with contract stipulations and protocols, they prepare, distribute, track and file contract and clinical trial documents. Due to legal and ethical issues associated with contracts and clinical trials, they must adhere to stringent guidelines covering all aspects of the contracts and the trials. These dictate that the results are credible and the trial subjects as well as the University are protected.
The successful incumbent will have outstanding written, verbal, and interpersonal communication skills, an ability to analyze project budgets and pay close attention to detail, as well as experience successfully working independently as well as part of a team with a collaborative approach to problem solving. The incumbent must have experience effectively multi-tasking in a fast-paced, deadline driven environment with a high degree of accuracy and strong organizational and time management skills with exceptional attention to detail. This position requires the ability to thrive in a busy, high-volume, and deadline driven work team environment where there will be coordination of multiple activities and the judgment and flexibility to reprioritize to accommodate emergency requests. The incumbent must possess experience interacting with individuals at various levels within an institution as well as the general public whenever necessary and the ability to speak confidently when communicating with investigators and industry professionals.
- Draft, review, negotiate, execute and administer a variety of
complex contract types, including basic science industry sponsored
research agreements (SRAs), data use agreements (DUAs), clinical
trial agreements (CTAs) - sponsor or investigator-initiated,
testing/lab study agreements, amendments, and other complex
agreements 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. As the University
authorized representative, exercises independent judgment to
provide guidance and interpretation of contract terms, federal,
state, and local laws, and institutional policies and procedures
internally and externally to resolve issues and to ensure
compliance, and directly works with outside patent counsel in the
process of negotiating agreements. Ensures contract budgets and
contract related documentation adhere to institutional policy and
practice. Provides liaison between and among faculty and corporate
sponsors, campus administrative offices, OVPR units, and the 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). Forges
Master Clinical Trial agreements for Stony Brook University and the
entire SUNY system.
- Collaborate via phone, email and in-person meetings with
investigators and their staff on all facets of grant and contract
administration, with particular emphasis on clinical research
accounts, and adheres to the organization's high service level
agreement response times.
- Enter contract negotiations and correspondence into SBU's
electronic systems. 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. Monitors submission of progress
reports. Follows, develops, and updates established processes to
ensure metrics and tracking, compliance, document harmonization,
and timely execution of contracts.
- Provide training and mentorship to contracts and clinical
trials entry sponsored programs staff. Maintains an awareness of,
and disseminates information to management and staff on laws,
regulations and nuances that may impact contracts operations. Act
as back up for the team of contracts administrators in OSP as
- Participate in sponsored programs administration policy
discussions and recommend revisions, update or develop effective
and skillful practices related to clinical research at the
University as necessary. Assist in the development and
implementation of internal contracting policies and procedures.
Enhance and keep Office of Sponsored Programs clinical trials
- Represent Office of Sponsored Programs at campus and external
meetings. Provide clinical research presentations and informational
sessions to the campus community.
- 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.
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).
This position may be eligible for alternative workplace arrangements/telework (remote or virtual).
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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