Policy Analyst (Human Subjects Research/Protection) (Part-Time) (52057)

GAP SOLUTIONS INC•Durham, NC

27d•$60 - $85•Onsite

About The Position

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).

Requirements

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

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