Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with the leading medical research center in the world. We are seeking an experienced individual to work as a Human Subjects Protection Specialist at the National Institutes of Health in Rockville, MD.
This is a long-term contract position which offers: - Competitive compensation and comprehensive benefit package - Optional health, vision, and dental plans - Vacation leave as well as 10 paid federal holidays and 401K plan. - Access to NIH’s unparalleled resources and niche scientific initiatives
TASKS/SERVICES. The contractor shall: (1) Provide human subject protections related advice and guidance on protocols and associated documents (2) Participate in Prevention/Clinical Science Review Committees and full regulatory reviews as applicable and provide advice on human subject protections-related aspects of the protocol under review. (3) Provide advice on human subject protections-related aspects of the protocol and related documents throughout the lifecycle of the protocol. (4) Possess and maintain knowledge of pertinent human subject protections regulations including Office for Human Research Protections (OHRP), Food and Drug Administration (FDA) regulations, and ICH guidelines. (5) Contribute to and participate in inspection preparedness activities (6) Maintain up-to-date knowledge of regulatory and policy changes including new and existing guidance documents on human subject protections. (7) Interpret human subject protection regulations and policies in a clear and consistent manner. (8) Advise the branch chief and director of any significant/relevant changes to the requirements that relate to human subject protections. (9) Provide advice and status updates and recommendations to the departmental branch chief such as on resolution of issues or related administrative tasks (10) Develop briefings for the protocol team, departmental Branch Chief, and senior office and Division leadership
REQUIREMENTS. The contractor must have: (1) Bachelor’s degree in Biology, Public Health, Nursing, or a related discipline. Advanced degree (Master’s or Ph.D.) in relevant field preferred. (2) Minimum of 5 years of experience in the field of human subject protection and policy development from both site and sponsor perspectives (3) Experience with clinical research protocols and operations along with knowledge of federal regulations and guidelines
PLEASE APPLY ONLINE When you apply, please know a Kelly Government Solutions Recruiter will review your resume and will contact you directly, if your skills and experience match the requirements of this position; a full job description can be made available at that time.
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