Chief of Research Oversight and Compliance

at  Ripple Effect

DO YOU HAVE A PASSION FOR INNOVATIVE BIOMEDICAL RESEARCH THAT MAINTAINS THE HIGHEST ETHICAL STANDARDS? DO YOU HAVE A BROAD RANGE OF EXPERIENCE IN REGULATORY PROCESSES SUCH AS PATENTS, TECH TRANSFERS, AND THE PROTECTION OF INTELLECTUAL PROPERTY?

Ripple Effect is looking for a Chief of Research Oversight and Compliance (Chief ROC) with eight years of experience to support our client’s mission. This individual will work closely with Travis Air Force Base David Grant Medical Center/Clinical Investigation Facility (CIF) to work with clients, colleagues, and stakeholders to support all clinical research from a quality assurance, legal, and ethical perspective. Working with a team of scientists and clinical research nurses, the Chief ROC will oversee a biomedical research portfolio that focuses on improving the mission capabilities of the U.S. Air Force, Space Force, and NASA and is strongly aligned with Defense Health Agency and the Air Force Surgeon General’s strategic initiatives.
If this position sounds of interest, there’s a place for you here at Ripple Effect! We are a diverse, progressive, and engaging work environment. We offer a multitude of incentives and flexible work options that work for you and your lifestyle.

General Information

• Job Code: SHR-RA-04T
• Location: Travis Air Force Base - Fairfield, CA
• Employee Type: Exempt, Full-Time Regular(Ask our recruiters about flexible work arrangements)
• Telework: None
• Clearance: NACI
• Number of Openings: 1
• Salary Range: $115,000.00 - $125,000.00 / annually (how we pay and promote)

Responsibilities

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:

• Coordinate a team approach to produce the monthly IRB agenda for each meeting and help ensure that materials are distributed within established guidelines
• Attend IRB meetings, record deliberations, 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
• Provide direct guidance (but not supervision), and serve as a resource, to coworkers in the IRB office
• Monitor the regulatory environment and recommend changes, as needed, to institutional officials

Provide guidance and oversight of an electronic IRB system (eIRB).

• Coordinate appropriate training to implement and maintain eIRB
• Manage the day‐to‐day maintenance of eIRB
• Facilitate uploading all appropriate documents and files to eIRB

Perform the following additional functions, as needed:

• 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 proper documentation and submission of appropriate disclosures to protect the rights of the Air Force and its collaborators
• 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

• Masters’ Degree in a related field
• 8 years of IRB and related regulatory experience

BASIC REQUIREMENTS

• Strong background in IRB procedures and human subjects research policies
• Experience advising, drafting, and coordinating collaborative agreements (CRADAs)
• Experience with invention disclosures, patents, patent law and 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
  To be successful at Ripple Effect, you must be able to pay attention to details, clearly communicate, work independently, and have an eagerness to learn. Learn more about what it takes to become a Rippler here.

SKILLS THAT SET YOU APART

• CIP certification
• 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
  If you don’t have all of the skills above, 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!

• Coordinate a team approach to produce the monthly IRB agenda for each meeting and help ensure that materials are distributed within established guidelines
• Attend IRB meetings, record deliberations, 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
• Provide direct guidance (but not supervision), and serve as a resource, to coworkers in the IRB office
• Monitor the regulatory environment and recommend changes, as needed, to institutional official