Position Information: Full-Time, Regular, and On Client-Site
Vacancy: One Opening
Security Level: A security clearance is not required to apply. Applicants, once hired, may be subject to a security investigation and may need to meet eligibility requirements for access to classified information.
Travel Required:This position may require occasional travel for work-related meetings.
Relocation Expenses:No relocation expenses may be authorized for this position.
Citizenship: US Citizenship required.
The Chief of Research, Oversight, and Compliance (Chief, ROC) will provide oversight and guidance to the human protection and animal welfare programs at CIF. 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. The Chief, ROC will advise, draft and coordinate collaborative agreements, ensure Air Force Intellectual Property Rights are protected, and file invention disclosures, as needed.
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 amendment specific content
Perform initial and adjunct ethics and legal reviews of research applications for exempt and nonexempt review
Support initial legal review of site-specific Cooperative Research and Development Agreements (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 noncompliance 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, Non 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, research related education sessions
Prepare Institutional Animal Care and Use Committee (IACUC) agendas, meeting minutes, and other related duties, as required.
Other duties, as assigned
Master’s (alternative degrees may be accepted, with additional experience)
At least 4 years of IRB and related regulatory experience, having served in a leadership (chair or equivalent) IRB role
At least 8 years of relevant work experience
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
CIP certification (must be willing to acquire within a year)
CITI training in accordance with local IRB policy
Experience reviewing research collaborative agreements from a legal and regulatory perspective (e.g., CRADAs, Material Transfer Agreements, Non Disclosure Agreements, MOUs, MOAs, Work Plans, Patent Licensing Agreement, Interagency Agreements, Invention Disclosures, etc.)
Strong interpersonal and leadership skills
Internal Number: 221
About Ripple Effect
Ripple Effect works with federal, private, and non-profit clients to support some of the most crucial policies and programs that shape our nation. We provide professional consulting services in the areas of: Communications & Outreach; Program Management & Policy; and Research & Evaluation. Ripple Effect is an interdisciplinary environment, full of insightful and intentional people who value and reward adaptability, lifelong learning, and authenticity. To learn more about working at Ripple Effect and our growing team, check out the Careers section of our website.
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