Position Objective: The Policy Analyst will provide support services to satisfy the overall objectives of the National Institute of Environmental Health Sciences (NIEHS) within the National Institutes of Health.

Duties and Responsibilities:

• Act as the subject matter expert of laws, regulations and policies governing human subjects research and the approval of research by the NIEHS institutional review board and AAHRPP domains and accreditation
• Audit external websites, individuals, and departments internal to NIEHS
• Provide training for investigators, IRB members, and staff of the OHRC in federal regulations, NIH policies and guidance related to both Title 21 and Title 45 of the Code of Federal Regulations
• Write policies and procedures for the IRB and OHRC
• Provide advice to the OHRC staff on regulatory issues
• Develop and maintain policies governing human subjects research, the IRB process, and the compliance office
• Develop, maintain and analyze the corrective and preventive action program
• Document, summarize and analyze date from surveys
• Prepare audit reports and follow-up on findings
• Prepare CAPAs and follow-up on findings
• Provide manuscript writing and medical writing
• Provide advice on regulatory issues
• Provide support for NIEHS conference in the area of human subject research
• Work products and documents related to acting as subject matter expert on laws, regulations and policies governing human subjects research and approval; auditing external sites and internal individuals and departments.
• Work products and documents related to acting as subject matter expert on AAHRPP domains and accreditation; providing training on federal regulations, NIH policies and guidance related to Title 21 and Title 45 of the Code of Federal Regulations.
• Work products and documents related to writing policies and procedures for IRB and OHRC; developing and maintaining policies governing human subjects research, the IRB process and the compliance office.
• Work products and documents related to documenting, summarizing and analyzing data from surveys; preparing audit reports, CAPAs and follow-up on findings.
• Work products and documents related to providing manuscript and medical writing; providing advice on regulatory issues; supporting conference in the area of human subject research.

Basic Qualifications:

• Ph.D. Biological, Social Sciences, or Biomedical Sciences
• At least 20 years of experience

• Skilled in Institutional Review Board (IRB) amendments and continuing reviews
• Skilled in 45 Code of Federal Regulations (CFR) 46 and Human Subjects Research Protection

Preferred Qualifications:

• Ability to communicate effectively, orally and in writing, with non-technical and technical staff
• Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects

• This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at recruiting@gapsi.com. You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by law.

This position is contingent upon contract award.