Senior Policy Analyst - Human Subjects & IRB Expert

GAP SOLUTIONS INC; North Carolina; On-site; USD 10,000 - 155,000; Full time

Job summary

GAP SOLUTIONS INC. seeks an experienced regulatory expert to oversee human subjects research compliance for NIEHS OHRC. The role combines expert advisement on IRB processes with policy development and staff training on federal regulations (Title 21/45 CFR) and AAHRPP domains.

The candidate will develop, implement, and maintain comprehensive policies, provide CAPA support, and ensure regulatory alignment across internal and external stakeholders.

Qualifications

• Ph.D. in Biological, Social Sciences, or Biomedical Sciences.
• At least 20 years of experience.
• Skilled in IRB amendments and continuing reviews.
• Skilled in 45 CFR 46 and Human Subjects Research Protection.

Responsibilities

• Act as SME of laws, regulations and policies governing human subjects research and the IRB/AAHRPP domains.
• Audit external websites, individuals, and departments internal to NIEHS.
• Provide training for investigators, IRB members, and OHRC staff in federal regulations and NIH policies.
• Write policies and procedures for the IRB and OHRC.
• Provide regulatory advice to OHRC staff.
• Develop and maintain policies governing human subjects research and the IRB process.

Skills

IRB amendments

Continuing reviews

Regulatory compliance

Education

Ph.D.

Job description

GAP SOLUTIONS INC. seeks an experienced regulatory expert to oversee human subjects research compliance for NIEHS OHRC. The role combines expert advisement on IRB processes with policy development and staff training on federal regulations (Title 21/45 CFR) and AAHRPP domains.

The candidate will develop, implement, and maintain comprehensive policies, provide CAPA support, and ensure regulatory alignment across internal and external stakeholders.