Parsons Corporation Institutional Review Board Administrator in Camp Lejeune, North Carolina
Institutional Review Board Administrator
Naval Medical Center Camp Lejeune, NC
Parsons is seeking an Institutional Review Board Administrator (IRBA ) to support the Clinical Investigations Department (CID) at the Naval Medical Center Camp Lejeune (NMCCL). The individual will provide support to foster and facilitate operationally relevant clinical research programs directed toward enhancing the performance and survivability of military personnel as well as the protection and maintenance of the health of dependents.
NMCCL, CID is engaged in the advancement of scholar activity that is operationally relevant to both the Command and the community. CID currently supports a number of research efforts to include traumatic brain injury, post-traumatic stress disorder, alternative treatment therapies, prevention and treatment of mental health disorders and military training and readiness.
All efforts support the advancement of knowledge and to better support the warfighter and their families. The newly established Human Research Protection Program (HRPP) is tasked with the responsibility to safeguard and promote the health and welfare of human subjects.
Provide support for the IRB Chairman and is accountable for IRB administrative matters to the Clinical Investigation Department Head (CIDH). Independent judgment is exercised to determine appropriate action and priorities in the performance of duties.
Provide the Head, CID with monthly Metrics for DoD assessment of approved research protocols. Reports the data by maintaining a CID database of all research projects. The IRBA responds to unscheduled DoD queries on topics such as research related to military relevance, traumatic brain injury (TBI), post-traumatic stress disorder (PTSD), and combat readiness and training, etc. The IRBA has minimal supervision when satisfying both regular and unscheduled requests for data.
Assist in identifying ethical, legal, and other issues that might be controversial or counter to society’s mandates and suggests potential corrective measures to the investigator and CIDH for remediation. Report serious non-compliance issues to the IRB Chair.
Effectively manage deadlines, deliverables and coordinate with all involved parties to ensure schedule is adhered to.
Review Informed Consent Documents (ICDs) for Government protocol and amendment‐specific content and to ensure presence of federally mandated elements of informed consent.
Review all pertinent documents to ensure recipient compliance with established administrative and financial policies and procedures and sound business practices while utilizing knowledge of the technical administrative requirements of the protocol in order to recommend changes to the Principal Investigator (PI).
Receive protocols after they have been endorsed by the Research Quality Council (RQC)/ Scientific Research Council (SRC) and then assign the Government protocol to the IRB. The IRBA shall take the initiative to address any administrative complications as they arise and, if unable to achieve adequate resolution, seek the assistance of higher lines of authority.
Maintain files and records of ongoing research projects. Maintain a log of all correspondence and communication relating to the assigned duties.
Assist and consent subjects. Communicate with research subjects; via telephone or in person and ask relevant research questions as per protocol. Ensure that the consent process has taken place effectively and all questions are answered satisfactorily and documents. Arrange for research subject follow-up.
Provide direct guidance (but not supervision), and serve as a resource, to co-workers in the IRB office.
Monitor the regulatory environment and recommend changes, as needed, to institutional officials. Report adverse events to governing agencies and sponsors as required by protocol and regulations.
Ensure all studies performed are in accordance with the approved Government protocol and applicable regulations.
Create and disseminate the schedule and agenda for IRB meetings. The IRBA shall coordinate initial review of protocols with investigators and notifies investigators regarding administrative and IRB requirements. The IRBA shall coordinate continuing review of protocols with investigators and directs notification of investigators regarding administrative and IRB requirements.
Assist the CIDH and the IRB Chair with development and maintenance of the NMCCL IRB forms. Ensure that forms adequately document current study activity and regulatory criteria; such as inclusion of vulnerable populations, identification of risk level, and approval of Waiver of Consent or Waiver of Authorization of the use of PHI, so that expedited reviewers or the convened Board have sufficient information to take action upon submitted materials.
Work collaboratively with the IRB Chair, CIDH, DPE, and RAO to facilitate ongoing development, implementation, and maintenance of the human subject’s protection program.
Maintain patient confidentiality in accordance with HIPAA and institutional regulations. Assist the HIPAA Compliance Officer with the monitoring process to ensure compliance.
Minimum Education Requirements:
- A Bachelor’s Degree or higher in medicine, medical research, biological science, behavioral health, health science, physiology, or nursing is required. Post-baccalaureate advanced education to include a Master’s Degree or certification as a Registered Nurse is preferred
Minimum Experience Requirements:
- A minimum of four (4) years’ experience providing direct administration or management of a human subjects research IRB conducting active research protocols; OR a minimum of two years’ experience providing direct administration or management of a human subjects research IRB conducting active research protocols (four years preferred) with certification as a National Association of IRB Leaders (NAIM) Certified IRB Manager (CIM) or Public Responsibility In Medicine and Research (PRIMR) Certified IRB Professional (CIP).
- US Citizenship is required for this position
Must be able to obtain, maintain and/or currently possess a security clearance.
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