This position is located in the Office of Human Subjects Research Protections (OHSRP), Office of Intramural Research (OIR), Office of the Director (OD), National Institutes of Health (NIH). The OHSRP is established under the Deputy Director for Intramural Research (DDIR) in order to oversee the Intramural Research Program's (IRP) Human Research Protection Program on behalf of the Deputy Director, who serves as the NIH Human Research Protection Program (HRPP) Institutional Official (IO).

Duties

As an IRB Compliance Analyst, you will: Provide expert scientific and technical guidance to investigators and institute staff and act as the responsible point of contact in regard to review of all research activities that are considered human subjects research including both exempt human subjects research and human subjects research that requires IRB review. Serve as the primary contact regarding IRB procedures and regulatory requirements for reporting events such as non-compliance and unanticipated problems which occur in research conducted in the IRP. Participate in analyzing and evaluating operations and procedures in the Division and in developing and recommending ways to improve their effectiveness and efficiency in meeting regulatory and policy requirements related to human subject protections. Lead fact-finding investigations to determine if allegations of non-compliance are credible and if so, coordinate determinations and reporting to regulatory authorities. Conduct noncompliance investigations and QA/QI reviews of the NIH IRB. Coordinate compliance IRB meetings and agendas including scheduling presentations by consultants and principal investigators and monitor maintenance of quorum. Develop guidance materials, manuals, templates, job aids and other written and electronic resources on IRB compliance processes and function. Provide education and training for investigators, research staff, IRB members and IRB staff. Stay current with NIH policies, Federal Regulations, and professional literature relevant to IRB professional staff and relay the information via memoranda, email, forms, and reports as needed. Instruct and advise protocol management staff within the clinical research branches.

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.)
• Position requires Education.
• 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.

Qualifications

You qualify at the GS-13 level, if you meet the following qualification requirements: EDUCATION REQUIREMENT: 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. AND EXPERIENCE: 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: developing and conducting training initiatives within a human subjects research protections program (HRPP) such as educational tools, sessions or seminars; assisting individuals and groups at all levels of experience in defining educational needs related to conduct of human subjects research; identifying available internal and external informational resources and selecting educational formats to support the HRPP community in its efforts to advance clinical research that is compliant with regulatory requirements; identifying noncompliance with protocol or institutional policy requirements; conducting quality assurance (QA) and quality improvement (QI) activities. 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. 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. 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/12608333

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: Sandra Loether
• Phone: 3014357787
• Email: [email protected]