Chief of Research Oversight and Compliance

Position Overview

• Duty Location: Travis Air Force Base – Fairfield, California
• 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.

Job Description

What you'll do:

• 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

• 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

Requirements

Minimum Education and Experience

• Bachelor’s Degree
• 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

• 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

• 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.

Background

Benefits

• Health Benefits – Health, Dental, and Vision
• Life, long-term disability, and other insurance products
• Health and Wellness Programs
• Flexible Spending and Health Savings Accounts
• Retirement 401K program
• Profit sharing and bonus program
• Paid and unpaid leave
• Professional development
• Flexible schedules and work location

• qualified applicants will receive consideration for employment without regard to race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits;
• EOE/M/F/Vet/Disabled;
• employment eligibility will be verified using E-verify;
• applicants may be asked to participate in assessments during the interview process as described in our Informed Consent Policy; and
• applicants will not be reimbursed for any expenses associated with the interview process or relocation.