Senior Contracts & Clinical Trials Officer

SRA International; Stony Brook (NY); Presencial; USD 110.000 - 125.000; Jornada completa

Descripción de la vacante

Stony Brook University is seeking a Senior Contracts & Clinical Trials Officer to draft, negotiate, and manage research contracts, including clinical trial agreements, testing and laboratory study agreements, and industry‑sponsored contracts.

The role ensures compliance with university policies and federal/state regulations, coordinating with faculty, sponsors, and administrative offices to streamline contract execution and support pre‑ and post‑award activities.

Formación

• Bachelor's degree or foreign equivalent; if none, associate's degree + 2 years related experience may be considered.
• Three years of full-time experience negotiating/administering varied research awards.
• One year of full-time experience in research grants, subawards, or contracts.
• Knowledge of federal/state/university/industry rules governing grants and contracts.
• Juris Doctor (or foreign equivalent) preferred.
• Two additional years in a pre-award area preferred.
• Experience in clinical observational/interventional research administration.
• Familiarity with pre-award electronic routing/submission systems.
• Experience with Clinical Conductor, Oracle E‑Business Suite RF Report Center, PeopleSoft, and Google Apps for Education.
• Experience with industry, private, and government contracting.
• Experience negotiating terms/conditions of research grants/contracts, including post-award admin.
• Experience negotiating clinical trials contracts.

Responsabilidades

• Draft, negotiate, recommend acceptance, and administer research, testing, and lab study agreements, including sponsor or investigator‑initiated clinical trials, for a wide range of sponsors with emphasis on pharmaceutical industry.
• Act as university representative to sponsoring agencies and collaborate with outside patent counsel during negotiations.
• Assist PIs with budget formulation for investigator‑initiated clinical trials and serve as liaison with Compliance entities.
• Serve as liaison among faculty, corporate sponsors, campus administrative offices, and the School of Medicine / Office of Clinical Trials and Central Office of the Research Foundation.
• Work closely with OCT and other SOM areas to maintain clinical trials management systems (e.g., Clinical Conductor, OnCore) and contribute to future implementations.
• Provide assistance in contract proposal development, fiscal planning, and patent and licensing issues.
• Advise faculty and staff on all facets of grant and contract administration, with emphasis on clinical research accounts.
• Serve as primary expert in risk assessment and offer alternative contractual language to mitigate risks.
• Mentor new and junior contracts and clinical trials negotiators and update processes to reduce cycle time.
• Authorize accounts and fiscal transactions related to awards, including advances, budget increases, and term extensions with emphasis on clinical research accounts.
• Provide post‑award administrative support, including expenditure approvals, accounting detail, reporting, cost monitoring, progress reports, and closeout documents.
• Forge Master Clinical Trial agreements for Stony Brook University and the SUNY system.
• Track research projects/agreements and maintain a database of all sponsored clinical research initiatives.
• Represent the Office of Sponsored Programs at campus and external meetings and provide clinical research presentations.
• Other duties as assigned.

Conocimientos

Contract negotiation

Contract administration

Budget formulation

Regulatory compliance

Sponsor relations

Risk assessment

Educación

Bachelor's degree or foreign equivalent

Associate's degree + 2 years experience considered

Juris Doctor (preferred)

Herramientas

Clinical Conductor

OnCore

Oracle E‑Business Suite RF Report Center

PeopleSoft

Google Apps for Education

Huron/myResearch

Descripción del empleo

Senior Contracts & Clinical Trials Officer

Overview

Senior Contracts & Clinical Trials Officer

Qualifications

Required Qualifications:

• Bachelor's degree or foreign equivalent. If none, Associate's degree and 2 years of full‑time experience involving research grants, subawards, or contracts in a research setting may be considered.
• Three years of full‑time experience negotiating and/or administering a variety of research awards.
• One year of full‑time experience involving research grants, subawards, 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 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‑award electronic routing and submission systems.
• 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 negotiating the terms and conditions of research grants or contracts, including post‑award administration.
• Experience in negotiating clinical trials contracts.

Responsibilities

Brief Description of Duties: The 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.

• Draft, negotiate, recommend acceptance, and administer research, testing, and lab study agreements, including sponsor or investigator‑initiated clinical trials, for a wide range of sponsors with emphasis on pharmaceutical industry.
• Act as university representative to sponsoring agencies and collaborate with outside patent counsel during negotiations.
• Assist PIs with budget formulation for investigator‑initiated clinical trials and serve as liaison with Compliance entities.
• Serve as liaison among faculty, corporate sponsors, campus administrative offices, and the School of Medicine / Office of Clinical Trials and Central Office of the Research Foundation.
• Work closely with OCT and other SOM areas to maintain clinical trials management systems (e.g., Clinical Conductor, OnCore) and contribute to future implementations.
• Provide assistance in contract proposal development, fiscal planning, and patent and licensing issues.
• Advise faculty and staff on all facets of grant and contract administration, with emphasis on clinical research accounts.
• Serve as primary expert in risk assessment and offer alternative contractual language to mitigate risks.
• Mentor new and junior contracts and clinical trials negotiators and update processes to reduce cycle time.
• Authorize accounts and fiscal transactions related to awards, including advances, budget increases, and term extensions with emphasis on clinical research accounts.
• Provide post‑award administrative support, including expenditure approvals, accounting detail, reporting, cost monitoring, progress reports, and closeout documents.
• Forge Master Clinical Trial agreements for Stony Brook University and the SUNY system.
• Track research projects/agreements and maintain a database of all sponsored clinical research initiatives.
• Represent the Office of Sponsored Programs at campus and external meetings and provide clinical research presentations.
• Other duties as assigned.

Special Notes

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 overtime. 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 must be a U.S. citizen, lawful permanent resident, or other protected individual as defined by 8 U.S.C. § 1324b(a)(3).

Salary

$110,000 - $125,000

EEO Statement

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.