Policy Analyst (Human Subjects Research/Protection) (Part-Time) (51996)
About The Position
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. This role involves acting as a subject matter expert on laws, regulations, and policies governing human subjects research and the approval of research by the NIEHS institutional review board and AAHRPP domains and accreditation. The analyst will also audit external websites, individuals, and departments internal to NIEHS, and 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. Key responsibilities include writing policies and procedures for the IRB and OHRC, advising OHRC staff on regulatory issues, and developing and maintaining policies governing human subjects research, the IRB process, and the compliance office. The role also entails developing, maintaining, and analyzing the corrective and preventive action program, documenting, summarizing, and analyzing data from surveys, and preparing audit reports and follow-up on findings. Additionally, the Policy Analyst will prepare CAPAs and follow-up on findings, provide manuscript writing and medical writing services, offer advice on regulatory issues, and support NIEHS conferences in the area of human subject research.
Requirements
- Ph.D. in 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
Nice To Haves
- 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
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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
