The incumbent will serve as an Institutional Review Board (IRB) Analyst, with responsibility for independently providing expertise and scientific, analytical, and program support to the NIH Intramural IRB.

Duties

Provides expert scientific and technical guidance to investigators and institute staff regarding review of all research activities that are human subjects research. Participates in analyzing and evaluating IRB operations and procedures, in developing and recommending ways to improve their effectiveness and efficiency in meeting regulatory and policy requirements related to human subject protections. Works closely with Principal Investigators and other research staff to advise them of complex regulatory, ethical, and procedural requirements. Uses scientific knowledge and understanding of IRB processes to develop guidance materials, manuals, templates, job aids and other written and electronic resources. Stays current with NIH policies, Federal Regulations, and professional and scientific literature relevant to IRB professionals. Consults with Principal Investigators to assess real and potential clinical problems, determine priorities, and implement strategies to remain in compliance with Federal regulations. Reviews IRP protocol actions from a scientific and technical viewpoint prior to submission to the IRB for compliance with regulatory, policy, and procedural requirements and for completeness, appropriateness, and adequacy of information.

Requirements

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• Employment is subject to the successful completion of the pre-appointment process (i.e., background investigation, verification of qualifications and job requirements, completion of onboarding forms, submission of required documents, etc.)
• Males born after December 31, 1959 must be registered with the Selective Service.
• Applicants must meet all qualifications requirements within thirty (30) calendar days of the closing date of this announcement, including time in grade. Please include SF-50 with application.
• Position requires Education.

Qualifications

You qualify at the GS-12 level, if you meet the following qualification requirement: You must demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS-11 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: reviewing documentation for IRB submissions for completeness, accuracy and compliance with procedures; preparing IRB submissions for IRB full board review; drafting IRB correspondence to clinical study teams; and coordinating with Principal Investigators to facilitate their IRB requests. You qualify at the GS-13 level, if you meet the following qualification requirement: You must demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS-12 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: reviewing and evaluating IRB submissions for their compliance to regulations and policies; performing scientific planning and analysis of IRB submissions; monitoring, interpreting and communicating updates to organizational policies, government regulations and relevant scientific literature; and managing and coordinating the lifecycle of scientific and technical aspects of human subjects research submissions. Education Requirement: In addition to the previous requirements, you must demonstrate possession of a Bachelor's degree, or graduate/higher level degree with major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of this position. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained. Do not copy and paste the duties, specialized experience, or occupational assessment questionnaire from this announcement into your resume as that will not be considered a demonstration of your qualifications for this position. You will receive credit for all experience material to the position, including experience gained in religious, civic, welfare, service, and organizational activities, regardless of whether you received pay. To determine your qualifications and referral status, we may review your resume and supporting documentation and compare it against your responses to the vacancy questionnaire. Ensure you support your self-ratings with the information you provide in your application. We may verify or assess your qualifications at any time. Inflated or unsupported qualifications may affect your rating. Any misrepresentation or material omission of facts may be sufficient cause to end further consideration of your candidacy. Persons listed as knowing your past accomplishments or experience in your application may be contacted for verification purposes at any time. Verification may, but need not, begin before receiving an offer. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12574374

Education

This position has an education requirement. You are strongly encouraged to submit a copy of your transcripts (or a list of your courses including titles, credit hours completed and grades). Unofficial transcripts will be accepted in the application package. Official transcripts will be required from all selectees prior to receiving an official offer. Click here for information on Foreign Education.

Contacts

• Address National Institutes of Health 6701 Rockledge Drive Bethesda, MD 20892 US
• Name: Francesca Littman
• Phone: 301-451-7616
• Email: [email protected]