The National Institutes of Health, Office of the Director, Office of Intramural Research, seeks a Director for its Office of Human Subjects Research Protection (OHSRP). The positon is located on the NIH’s campus in Bethesda, Maryland. OHSRP is the Human Research Protection Program (HRPP) policy office in the Office of the Director in support of the Deputy Director of Intramural Research (DDIR) who is the Institutional Official at the NIH. OHSRP is located in the NIH Clinical Center, the largest hospital in the world totally dedicated to translational clinical research. The hospital maintains a 200-bed capacity that supports the intramural research programs of Institutes and Centers across the NIH. At any given time the Clinical Center has more than 1600 active clinical research protocols. Approximately half of these are studies of the pathogenesis or natural history of rare, frequently genetically determined, diseases, with the other half of the studies being clinical trials, more than 90% of which are Phase I or Phase II trials. All Clinical Center patients are research participants and many have long-standing relationships with their care teams.
This position offers a broad range of experience, significant responsibility and intellectually engaging work. OHSRP is responsible for setting policy for the conduct of research with human subjects in the NIH Intramural program, and ensuring compliance with all regulations and guidance regarding the protection of human subjects. In addition, the incumbent will be responsible for maintaining the accreditation of the human subjects research protection program. This accreditation was granted by the Association for the Accreditation of Human Research Protection Programs in 2014.
The ideal candidate will have strong leadership, supervisory and operational experience in running an IRB or similar program, and be very familiar with federal statutes and regulations, including the new Common Rule. She/he will possess the leadership capabilities to work in an interdisciplinary environment at a major research hospital. In addition, the candidate will manage the planning, coordination and implementation of major policy initiatives in the field of human subjects research with an emphasis on protecting the rights and welfare of human subjects, and will provide expert guidance and advice to NIH senior leadership on complex human subjects protections matters. In addition, she/he will ensure prompt regulatory reporting to the Office for Human Research Protections (OHRP) and the FDA. will be responsible for determining when NIH investigators are engaged in non-exempt human subjects research and will coordinate with the Clinical Center’s Patient Representative to investigate and resolve complaints related to human subjects research participation by subjects and their families. Excellent communication skills, written and oral, as well as a high level of expertise in the field of human subjects protection, are essential. Experience in the conduct of human subjects research as a clinical investigator is desirable, but not required.
This is an opportunity for a motivated self-starter with a deep commitment to the protection of human subjects, to have an impact on policy regarding subjects in clinical trials in the field of biomedical research. He/she will play a major role in protecting the safety of human subjects in clinical trials conducted throughout the NIH Intramural Program.
The closing date of this position is January 21, 2018.
Candidates must have successfully completed the requirements for Doctor of Medicine or Doctor of Osteopathy from a school in the United States or Canada approved by a recognized accrediting body in the year of the applicant's graduation, OR have successfully completed premedical education in the United States and graduate education from a foreign medical school that provided education and medical knowledge substantially equivalent to accredited schools in the United States that was demonstrated by permanent certification by the Educational Commission for Foreign Medical Graduates (ECFMG), OR have successfully completed a Doctor of Medicine or equivalent degree from a foreign medical school that provided education and medical knowledge substantially equivalent to accredited schools in the United States that was demonstrated by permanent certification by the Educational Commission for Foreign Medical Graduates (ECFMG). Also, they must have an active, current medical license as a physician in a State, District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States.
Salary is commensurate with experience, and includes standard federal employee benefits, (including retirement, health, life and long term care insurance, Thrift Savings Plan, etc.) Applications must be submitted via the www.usajobs.gov website, job announcement # NIH-OD-DH-18-10082891(https://www.usajobs.gov/GetJob/ViewDetails/487619700). If you have questions about this position, please contact Kim Farmer on 301-443-3358 or at email@example.com. This position is subject to a background investigation.
All qualified candidates will receive consideration without regard to race, color, age, religion, sex, national origin, political affiliation, sexual orientation, marital status, disability, or membership or non-membership in an employee organization. DHHS and NIH are Equal Opportunity Employers.
The National Institutes of Health (NIH) is the premier biomedical research center for the world. Its 27 Institutes and Centers employ approximately 18,000 employees doing a vast array of jobs, all supporting efforts for a healthy nation. For information on the NIH mission, goals, and Institutes and Centers, for more information visit NIH Overview at https://www.nih.gov/about-nih.
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