IRB Compliance & Policy Analyst

GAP Solutions Inc; Salt Lake City (UT); On-site; USD 120,000 - 190,000; Full time

Job summary

GAP Solutions, Inc. seeks a Policy Analyst to support NIEHS objectives within NIH, focusing on human subjects research oversight, IRB compliance, and AAHRPP alignment.

You will develop, write and implement policies for the IRB and OHRC, train investigators and staff on federal regulations (21 CFR and 45 CFR), audit sites, prepare CAPAs, and provide regulatory guidance across the office. This senior role requires a PhD and extensive experience in IRB processes, with strong communication and

Qualifications

• Ph.D. Biological, Social Sciences, or Biomedical Sciences.
• 20+ years of experience.
• Skilled in Institutional Review Board (IRB) amendments and continuing reviews.
• Skilled in 45 CFR 46 and Human Subjects Research Protection.

Responsibilities

• Act as the subject matter expert of laws, regulations and policies governing human subjects research and the approval of research by the NIEHS IRB 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 Title 21 and Title 45 CFR.
• 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 data 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.

Skills

IRB expertise

Policy development

Training delivery

Regulatory analysis

Education

PhD in biological/biomedical sciences

Job description

GAP Solutions, Inc. seeks a Policy Analyst to support NIEHS objectives within NIH, focusing on human subjects research oversight, IRB compliance, and AAHRPP alignment.

You will develop, write and implement policies for the IRB and OHRC, train investigators and staff on federal regulations (21 CFR and 45 CFR), audit sites, prepare CAPAs, and provide regulatory guidance across the office. This senior role requires a PhD and extensive experience in IRB processes, with strong communication and