| Human Subjects Protection Scientist -- Arlington, VA |
Author: Jon Merz
Date: 04-08-10 18:46
Human Subjects Protection Scientist
The Army Human Research Protections Office (AHRPO) seeks Human Subject Protection Scientists to assist with oversight of Army Human Research Protection Programs (HRPPs), human subject protection policy development, and HRPP education and training.
Major Duties Include:
- Assist in the development and implementation of Army Headquarters level human subject protection policies and procedures.
- Provide expert written technical reviews of application packets for DoD Assurances for the Protection of Human Research Subjects (Assurances). Application packets include, at a minimum, a DoD Assurance Agreement, Human Research Protection Program (HRPP) Plan, IRB roster, IRB Policies and Procedures, and summaries of HRPP training for key HRPP staff.
- Provide consultation for establishing and updating a Human Research Protection Program at the organization level. Review, analyze and revise site-specific policies and procedures that support the organization’s HRPP.
- Assess compliance with DoD Assurances by preparing, planning, conducting, and reporting on periodic HRPP assessments of Institutions holding DoD Assurances, determine compliance through interviews with personnel and a review of records (to include Institutional and human subject protection policies, guidelines, and SOPs; IRB minutes; and research files). Provide a written report of each assessment including specific findings and recommendations to bring the Institution into compliance and/or initiate quality improvements.
- Conduct Headquarters Level Administrative Review (HLAR) of research protocols reviewed by IRBs for which AHRPO has regulatory oversight responsibility. Provide a written HLAR report for each protocol that is reviewed. Work with IRB staff and investigators as needed to bring the research, and the IRB review of the research, into compliance.
- Provide expert human subject protection and regulatory compliance advice to investigators, research managers and administrators, Institutional Review Board (IRB) members and other regulatory staff on implementing human subject protection and regulatory compliance policies and procedures as they apply to human subject research conducted by Army personnel or otherwise supported by the Army.
- Develop, coordinate and conduct innovative education and training programs designed to foster human subject protection regulatory compliance. Prepare appropriate training support material.
Requirements:
- Doctoral degree with extensive HRPP and IRB experience preferred; Masters degree with extensive post-master’s degree HRPP and IRB education and experience considered.
- Extensive education, training and experience in human subjects protection, including application of the Common Rule and Subparts B, C and D; the Food and Drug Administration (FDA) regulations concerning investigational devices and drugs; HIPAA; and other human subjects protection regulatory requirements.
- Minimum of 4 years experience in IRB management.
- Exceptional communication skills (verbal and written), with proven technical writing abilities. Writing sample required.
- Superior analytic, problem solving, and negotiating skills.
- Excellent project and time-management skills.
- Demonstrated success in change management.
- Travel required.
Highly Desirable:
- Experience conducting human subject research.
- A minimum of 1 year experience serving as an IRB Chair or IRB member.
- Previous DoD experience in the area of human subjects protection and regulatory compliance.
- Human subjects protection and regulatory compliance certification, such as Certified IRB Professional (CIP).
Please apply on-line at www.afsc-usa.com. Click Careers and Browse our open positions and click on job number 10-034 Research Integrity, Compliance and Education Specialist.
Our Equal Employment Opportunity Policy: Armed Forces Service Corporation (AFSC) is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.
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| Topics |
Author |
Date |
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Human Subjects Protection Scientist -- Arlington, VA |
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Jon Merz |
04-08-10 18:46 |
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