Senior Policy Analyst, Human Subjects Research & Protection

GAP Solutions Inc; North Carolina; On-site; USD 120,000 - 180,000; Full time

Job summary

GAP Solutions Inc. seeks a Policy Analyst (Human Subjects Research/Protection) to support NIEHS within NIH, serving as expert on laws and policies governing human subjects research.

You will audit sites, train investigators and staff, write IRB/OHRC policies, and assist with regulatory issues across Title 21 and Title 45 CFR. Strong communication, analytical, and organizational skills are essential.

Qualifications

• Ph.D. in Biological Sciences, Social Science, Biomedical Sciences, or similar.
• 22 years of experience.
• Ability to communicate effectively, orally and in writing, with non-technical and technical staff.

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 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

Communication

Detail-oriented

Organizational skills

Education

Ph.D. in Biological Sciences, Social Science, Biomedical Sciences, or similar

Job description

GAP Solutions Inc. seeks a Policy Analyst (Human Subjects Research/Protection) to support NIEHS within NIH, serving as expert on laws and policies governing human subjects research.

You will audit sites, train investigators and staff, write IRB/OHRC policies, and assist with regulatory issues across Title 21 and Title 45 CFR. Strong communication, analytical, and organizational skills are essential.