24.33 IRB Coordinator

SierTeK proudly serves our clients by providing expertise in the Program Management, Information Technology, and Administrative Support domains. Founded in 2007 as a minority and service-disabled veteran-owned company, we serve as prime- and subcontractor for a multitude of Federal Department of Defense contracts. By focusing on continual improvement, our services remain at the forefront of our industry, and we pride ourselves on delivering our services with the highest degree of integrity.

SierTeK Ltd. is seeking an IRB Manager to support an opportunity at Wright Patterson AFB.

POSITION OVERVIEW SECTION 

The Air & Space Biosciences Division is seeking an experienced and motivated IRB Coordinator. This position plays a crucial role to ensure research involving human subjects adheres to ethical standards and regulatory requirements. The IRB Coordinator is responsible for managing the administrative aspects of the IRB process. This includes facilitating the review of research protocols involving human subjects, ensuring compliance with regulatory guidelines, and serving as the primary resource/liaison for researchers, relevant stakeholders, and IRB members. The successful candidate will have excellent organizational, management, and strong communication skills to be able to work well under pressure.

The employee shall interface with 711HPW/RHB leadership and staff, 711 HPW Staff, as well as USAF experts and consultants in this field. The contractor employee shall provide research and basic science coordination, and general assistance in areas required to meet the stated work and objectives.

Essential Job Functions

• Serve as the IRB subject matter expert to the Air & Space Biosciences Division, to include Principal Investigators (PIs) and leadership team.
• Manage the preparation and review process for proposals to include pre-review assessments, review coordination with IRB members, and protocol requirements to PI’s; ensure all submissions adhere to regulatory and federal guidelines.
• Schedule, coordinate, and manage IRB meeting activities, including preparing meeting materials and attendance.
• Continually monitor ongoing research efforts to ensure continued compliance with IRB-approved protocols and regulatory requirements.
• Manage and maintain the maintenance for all records/files of IRB activities, including protocol submissions, reviews, approvals, and correspondence. 
• Records the decision-making process of the IRB in official minutes. The contractor employee shall document:
• Summarization of any controverted issues and their resolution.
• Clearness about the actions of the IRB and exactly what the IRB approved.
• Clear specifications of any modifications required to obtain approval.
• Degree of risk.
• Specific required determinations.
• Members present at the meeting, members entering and leaving the meeting, alternate members attending and for whom they are substituting.
• Votes on actions:
  • Names of IRB members who abstain.
  • Names of IRB members who absent themselves due to conflict of interest.
  •  Attendance at the meeting for each action, basis for IRB requiring change in research, basis for disapproval of research, the rationale for significant or non-significant risk determinations, approval periods, and other regulatory requirements.
• Basis for IRB requiring change in research, basis for disapproval or research.
• Rationale for significant or non-significant risk determinations.
• Approval periods.
• Other regulatory requirements.

Minimum Position Requirements

• Master’s degree required with at least 5 years of demonstrated related work experience as detailed in PWS tasks 
• Strong understanding of regulatory compliance and guidelines for governing human subjects research and protection such as Common Rule, FDA regulations, HIPAA demonstrated through their relevant work experience.
• Ability to be highly skilled in the preparation, submission, and review of research protocols to provide guidance on ethical considerations, and maintains documentation related to the review process.
• Strong ability to manage multiple competing priorities with a high attention to detail.
• Ability to obtain and maintain a U.S. government security clearance (U.S. citizenship required).
• Demonstrated success in strategic thinking, collaboration, and analytical problem solving.
• Excellent communication, interpersonal, and organizational skills; adept at in-person and remote communications.
• Ability to adapt to new, various software and applications.
• Desired Qualifications
• Master’s degree in advanced science, management, public health, or health sciences.
• Familiarity with the Air Force Research Laboratory's mission, objectives, and research priorities.
• Prior experience working in military or defense research organizations, with an understanding of the unique requirements, processes, and constraints associated with these environments.
• A track record of managing and executing research and development projects within the Department of Defense (DoD) framework, including knowledge of relevant policies, funding sources, and reporting requirements.

SierTeK is an equal opportunity employer and values diversity. Employment is decided based on qualifications, merit, and business need. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected Veteran status, gender identity and sexual orientation.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfer, leaves of absence, compensation, and training.

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