Policy Analyst (Human Subjects Research/Protection) (Part-Time) (51996)

Job Details

Position Type: Full Time. Level: Experienced. Education Level: Ph.D. Salary Range: $10,000.00 – $155,000.00 per year. Travel Percentage: None. Job Shift: Day. Job Category: Public Health.

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 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.
• 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.

Basic Qualifications

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

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.

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.