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Chief of Research Oversight and Compliance - Fairfield, CA

Company: Kelly Services
Location: Fairfield
Posted on: September 13, 2020

Job Description:

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Chief of Research Oversight and Compliance - Fairfield, CA Location Fairfield, CA, USA Job Id: US3179KF_BH1594325 Category: Science/Clinical Posted Date: 09-Aug-2019

Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the government, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world. We are currently seeking a Chief of Research Oversight and Compliance to work onsite with a prestigious research institute in Fairfield, CA.

This is a direct hire position which offers a competitive salary with comprehensive benefit package.

Job Description

The Chief of Research Oversight, Compliance and Outreach (Chief, ROC) will provide oversight and guidance to the human protection and animal welfare programs. Extensive understanding of human subject research regulations and federal guidance documents is critical. The Chief, ROC will serve as the principal communications advisor to the Clinical Investigations Director on all collaborative research development. The Chief, ROC will be responsible for coordinating diverse outreach activities that involve facilitating collaborations between Principal Investigators (PIs), Resident Researchers and Faculty with other government agencies, industry, academia, and other related research organizations.

Specific duties may include:

Perform the following primary Institutional Review Board (IRB) functions: Review new applications in support of clinical investigations/research to ensure consistency, completeness, and compliance with federal and state regulations, as well as institutional guidelines

Work with PIs to ensure that research applications are complete; communicate outcomes of research applications

Review Informed Consent Documents (ICDs) for protocol and amendmentâ??specific content

Perform initial and adjunct ethics and legal reviews of research applications for exempt and nonâ??exempt review

Support initial legal review of site-specific CRADAs and invention disclosures

Support ongoing compliance and management of program audits of sponsored research programs

Evaluate reports of unanticipated problems, protocol amendments and continuing review forms, and prepare recommendations to the IRB committee

Report serious nonâ??compliance issues to the IRB

Perform the following IRB administrative duties in support of IRB operations:  Coordinate development of the monthly IRB meeting agenda and help ensure that materials are distributed within established guidelines

Work with other members of the team, attend IRB meetings, record deliberations, and document meeting minutes for IRB Chair approval

Assist in developing, recommending, and implementing policies and procedures to enhance efficiency of committee operations and general office functions

Assist with training and orientation tasks of new committee members

Monitor the regulatory environment and recommend changes, as needed, to institutional officials

Provide guidance and oversight to an electronic IRB system (eIRB), including coordinating training, managing maintenance, and uploading appropriate documents

Support and coordinate internal and external audits of all human research projects to ensure all appropriate regulations are followed. Facilitate periodic audits of all IRB-approved research studies, and ensure findings are appropriately documented and any deficiencies adequately addressed

Interact with medical center project personnel and contribute to strategies to bridge capabilities with researchers and external collaborators:  Draft, edit, and track research collaborative agreements to include: CRADAs, Material Transfer Agreements, Nonâ??Disclosure Agreements, MOUs, MOAs, Work Plans, Patent Licensing Agreement, Interagency Agreements, Invention Disclosures, etc.

Review research plans and collaborative agreements for potential intellectual property rights and invention disclosures

Ensure all required communications, reports, and agreements are submitted and approved through the proper chain of command

Perform the following additional functions, as needed:  Maintain collaborative team relationships with peers, colleagues and customers in order to effectively contribute to the working group’s achievement of goals and help to foster a positive work environment

Attend seminars, workshops, and conferences in order to gain insight into new trends in human and animal research and to learn new approaches for the application of federal regulations

Participate in, or present at, researchâ??related education sessions

Prepare Institutional Animal Care and Use Committee (IACUC) agendas, meeting minutes, and other related duties, as required.

Other duties, as assigned

REQUIREMENTS. The contractor must have:

Master’s or JD

At least 8 years of relevant work experience

IRB and related regulatory experience

Familiarity and/or experience with patent law or related areas

Highly organized, efficient, and extremely detail-oriented

Demonstrated strength in verbal and written communication skills; including professional emails

Must work effectively in a team environment

Ability to prioritize among multiple projects in a fast-paced, deadline-driven environment, relying on your own resources and initiative

Ability to work productively in Microsoft Office Suite, including Microsoft SharePoint to accomplish tasks

AboutKelly Services ® As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.

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Keywords: Kelly Services, Fairfield , Chief of Research Oversight and Compliance - Fairfield, CA, Other , Fairfield, California

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