PRIM&R accepts advertisements from all institutions seeking to hire for positions in animal and human research ethics and related fields, such as research administration and ethics education; listing does not imply endorsement of the lister or of the qualifications stated for a position.
Position Information: Full-Time, Regular, and On Client-Site
Vacancy: Single 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, Compliance 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.
What you'll do:
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 non?exempt 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 non?compliance issues to the IRB
Perform the following IRB administrative duties in support of IRB operations:
Assist with training and orientation tasks of new Principal Investigators (PIs)
Monitor the regulatory environment and recommend changes, as needed, to institutional officials
Provide direct guidance (but not supervision), and serve as a resource, to coworkers in the HRPO office
Monitor the regulatory environment and recommend changes, as needed, to HPA and institutional officials.
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
Minimum Education and Experience
10 (or more) years of relevant work experience
4 years of IRB and related regulatory experience, having served in a leadership (chair or equivalent) IRB role
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
Skills that set You Apart
If you don’t have all of the skills below, don’t be discouraged—no resume paints a complete picture of a person. There’s a good chance you’re more wonderful than you think, so please apply!
Master’s Degree or JD
CIP certification (must be willing to acquire within a year)
CITI training in accordance with local IRB policy
Familiarity and/or experience with patent law or related areas
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
What Makes a Successful Rippler?
This job description is not intended to be an exhaustive list of all duties, responsibilities, and skills required to be successful in the role. Other duties may be assigned to help make our clients successful and achieve our company goals. We have designed the introductory period to convey company core values and clear expectations of your role.
You pay attention to the details. Anything worth doing is worth doing right, every single time. So you stay organized, meet commitments and deadlines, work efficiently, and always check your work.
You communicate clearly. You consider your audience and take care to get your points across professionally and concisely, both in writing and when speaking to others. You’re comfortable interacting with clients, coworkers, and stakeholders, and respect everyone’s perspective.
You work independently. You know how to manage competing deadlines on multiple simultaneous projects, and can adapt when you need to re-prioritize. When you’re stuck, you take initiative to find resources, and you’re comfortable asking for help when you need it.
You’re eager to learn. You have a track record of learning new things, especially programs, technology, and processes. You embrace change, and if you can’t find a teacher, you teach yourself. Once you learn something new, you are excited to evaluate it and teach it to others.
Additional Salary Information: Please provide salary expectations - this is an on-site position.
Internal Number: 340
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.