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Institutional Review Board Administrative Support Services

Location NC - Camp Lejeune

Job Code 13003

# of openings 1

The Alaka`ina Foundation Family of Companies (FOCs) is possibly looking for an Institutional Review Board Administrative Support to provide research support administration services for our government customer at Camp Lejeune, NC.

DESCRIPTION OF RESPONSIBILITIES:

+ Provide support for the IRB Chairman and is accountable for IRB administrative matters to the Clinical Investigation Department Head (CIDH). Work is evaluated by observation and outcomes for effectiveness of operations and compliance with medical requirements and professional standards in terms of quality and appropriateness. 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 RPS 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.

+ Other duties as assigned by Supervisor.

REQUIRED DEGREE/EDUCATION/CERTIFICATION:

A Bachelor’s Degree or higher in medicine, medical research, biological science, behavioral health, health science, physiology, or nursing is required.

REQUIRED SKILLS AND EXPERIENCE:

+ A minimum of four 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).

REQUIRED CITIZENSHIP AND CLEARANCE:

+ Must be U.S. Citizen

+ Must pass a NACI background check and be eligible for a CAC card.

The Alaka`ina Foundation Family of Companies (FOCs) is a fast-growing government service provider. Employees enjoy competitive salaries. Eligible employees enjoy a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid time off; and 11 paid holidays.

We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We are proud to state that we do not illegally discriminate in employment decisions on the basis of any protected categories. If you are a person with a disability and you need an accommodation during the application process, please click here to request accommodation. We E-Verify all employees

•EOE, including Disability/Vets” OR “Equal Opportunity Employer, including Disability/Veterans”

The Alaka`ina Foundation Family of Companies (FOCs) is comprised of industry-recognized government service firms designated as Native Hawaiian Organization (NHO)-owned and 8(a) certified businesses. The Family of Companies (FOCs) includes Ke`aki Technologies, Laulima Government Solutions, Kūpono Government Services, and Kapili Services, Po`okela Solutions, Kīkaha Solutions, LLC, and Pololei Solutions, LLC. Alaka`ina Foundation activities principally benefit the youth of Hawaii through charitable efforts which includes providing innovative educational programs that combine leadership, science & technology, and environmental stewardship.

For additional information, please visit www.alakainafoundation.com

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