Odyssey Systems is pursuing a new opportunity for a Chief, Research Oversight, and Compliance who will support the Travis Air Force Base (AFB) David Grant Medical Center/Clinical Investigation Facility (CIF). Their mission is assisting with the execution of DoD medical research requirements accomplished through the performance of clinical studies and programs. This position is located at Travis AFB in Fairfield, CA.

***Contingent upon contract award***

Duties include, but not limited to:

The Chief, Research Oversight, Compliance (Chief, ROC) will provide oversight and guidance to the human protection and animal welfare programs at the Clinical Investigations Facility. Work is completed in accordance with the processes and procedures that ensure compliance with federal and state regulations and institutional policies relative to research at the Clinical Investigations Facility, 60th Medical Group. 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. In addition, the Chief, ROC will advise, draft and coordinate collaborative agreements, ensure Air Force Intellectual Property Rights are protected, and file invention disclosures as needed.
• The Chief, ROC shall perform the following primary Institutional Review Board (IRB) functions in support of research protocols:
  • Review new research applications in support of human model clinical investigations/research and other related research requirements to help ensure consistency, completeness, and compliance with federal and state regulations as well as institutional guidelines prior to IRB review. Work with Principal Investigators (PIs) to ensure that research applications are complete. Communicate to PIs items requiring clarification, or documents required for submission, prior to IRB review.
  • Review all complete project submissions, determine review type, recommend assignment for reviewers, and recommend exempt status.
  • Review Informed Consent Documents (ICDs) for protocol and amendment-specific content and help ensure presence of federally mandated elements of informed consent.
  • Provide written correspondence to PIs communicating the outcome of the research application by the IRB. Note: the IRB is comprised of Government representatives.
  • Provide support as in-house advisor to administration and researchers for DoDI 3216.02
  • Perform initial and adjunct ethics and legal reviews of research applications for exempt and non-exempt review.
  • Support initial legal review of site specific CRADAs and invention disclosures.
  • Support preparation of Institutional Animal Care and Use Committee (IACUC) agendas, meeting minutes and other animal protection-related duties as required.
  • 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 Director (a Government representative).
• 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.
• Work with other members of the team, 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.
• Support and coordinate internal and external audits of all human research projects.\
• Provide guidance and direction for any internal audits of human research studies to ensure all appropriate regulations are followed
• Coordinate and support any external audits of human research projects
• Facilitate periodic audits of all IRB-approved research studies, and ensure findings are appropriately documented and any deficiencies adequately addressed.
• Interact with DGMC project personnel to include investigators, residents, faculty, affiliated scientists, external committee members, etc. and contribute to strategies to bridge capabilities with DGMC 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 proper documentation and submission of appropriate disclosures to protect the rights of the Air Force and its collaborators.
• Ensure all required communications, reports and agreements are submitted and approved through the proper chain of command.
• Perform the following additional functions, as needed, in support of Clinical Investigation Facility operations.
• 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 (as budget will allow) in order to gain insight into new trends in human and animal research and to learn new approaches for the application of federal regulations, particularly in an atmosphere of increasingly sophisticated technology.
• Participate in, or present at, research-related education sessions.
• Work collaboratively with the IRB Chair to facilitate ongoing development, implementation and maintenance of the human subject's protection program.
• Assist in preparing Institutional Animal Care and Use Committee (IACUC) agendas, meeting minutes and other related duties as required.

Minimum Required Qualifications:

Citizenship: Must be a US citizen

Clearance: NACI (Able to obtain)

Education: MA/MS (or JD); PhD preferred

Years' experience:

* 6 years with IRBs, human protection, and animal welfare programs
* Experience advising, drafting, and coordinating collaborative agreements (CRADAs), invention disclosures, and patents
* Experience as communications advisor on collaborative research development projects
* Strong background in IRB procedures and human subject policies

Knowledge:

* Extensive understanding of human subject research regulations and federal guidance documents is critical.
* Excellent intrapersonal/communication skills

Preferred Experience:

* 8 years' experience

Additional Information:

Location: Travis AFB, CA

Travel: up to 10%

Remote, Onsite, or Hybrid: Onsite

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Odyssey Systems Consulting Group, is an innovative small business committed to providing world-class technical, management, and training support services to government and public sector clients. We focus on people, processes, and performance to deliver superior results. Since our inception in 1997, our commitment to mission success and customer satisfaction has been recognized with exponential growth and exceptional past performance ratings. We accept challenging assignments and drive projects from the planning stages, through implementation, and into operations and support.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Final compensation for this position will be determined by various factors such as the Federal Government contract labor categories and contract wage rates, relevant work experience, specific skills and competencies, geographic location, education, and certifications.

Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, Tricare supplement, short-term disability, long-term disability, 401(k) match, flexible spending accounts, health savings accounts, employee assistance program, learning and development benefit, paid time off, and holidays.

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