Senior Contracts & Clinical Trials Officer

Stony Brook University•Town of Brookhaven, NY

5d•Onsite

About The Position

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 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 the 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. Draft, negotiate, recommend 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. 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 New mentorship to new and Jr. 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 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. Tracking research projects/agreements and collection of 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.

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.
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 the 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.
U.S. citizen, lawful permanent resident, or other "protected individual" (as defined by 8 U.S.C. Sec. 1324b(a)(3)).

Nice To Haves

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 the terms and conditions of research grants or contracts, as well as post award administration.
Experience in clinical trials contracts negotiations.

Responsibilities

Draft, negotiate, recommend acceptance and administering of 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 (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.
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.
Provide new mentorship to new and Jr. 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 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 collection of data for internal and external purposes.
Maintain 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.