Policy Analyst (Human Subjects Research/Protection) (Part-Time)

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

Position Objective:

Provide support services as a Policy Analyst (Human Subjects Research/Protection) in support of the overall operational objectives of the National Institute of Environmental Health Sciences. within the National Institutes of Health (NIH).

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 Codeof 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.

Qualifications

Basic Qualifications:

• Ph.D. in Biological Sciences, Social Science, Biomedical Sciences, or similar
• 22 years of experience

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.

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._