This Program Specialist position serves as an Institutional Review Board (IRB) Coordinator, with responsibility for assisting with administrative, analytical, and program support to the NIH Intramural IRB.

Duties

Assists IRB Analysts in managing and coordinating all administrative aspects of the continuing reviews of 2500+ approved IRP protocols. Manages the monitoring and coordination of the extensive protocol continuing review schedule and guides Principal Investigators through the requirements and upcoming deadlines for submission of continuing review documentation to ensure compliance with regulations. Coordinates IRB meetings and agendas including scheduling presentations by consultants and Principal Investigators and monitors maintenance of quorum. Assures that all NIH IRB policies and procedures are disseminated via written and electronic communication to investigators, clinical staff, IRB members, Clinical Directors, and other Institute officials. Relays information via memoranda, email, forms, and reports when requested by IRB analysts on information pertaining to NIH policies, Federal Regulations, and professional literature relevant to IRB professional staff. Performs data compilation for IRB Analysts and prepares specialized reports for IRB Analysts required to extensively track compliance deadlines.

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 a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.
• Applicants must meet all qualification requirements by the closing date of this announcement.
• Males born after December 31, 1959 must be registered with the Selective Service.
• The National Institutes of Health participates in the USCIS Electronic Employment Eligibility Verification Program (E-Verify). E-Verify helps employers determine employment eligibility of new hires and the validity of their Social Security numbers.
• The NIH maintains a tobacco free work environment and campus.
• Must be able to perform the essential duties of the position, with or without reasonable accommodation.
• A one-year probationary period may be required upon selection/placement.

Qualifications

You qualify at the GS-11 level, if you meet one of the following qualification requirements: You must demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS-09 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: reviewing human subject research protocols for completeness, accuracy, and compliance with federal regulations and institutional policies; providing administrative support for a portfolio of human subject research protocols to include coordination of timely reviews, facilitating IRB meetings including the pre and post processing; AND coordinating with study teams to facilitate their Institutional Review Board (IRB) review and approvals; OR Completion of a Ph.D. or equivalent doctoral degree, or 3 full years of progressively higher level graduate education leading to such a degree or an LL.M., if related. 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. OR A combination of education and specialized experience that meets the qualification requirements 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. 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 application questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12511722

Education

If you qualify based on education in lieu of specialized experience, 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 packages. 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]