Duties

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• Provide regulatory and protocol navigation support for assigned portfolio of clinical trials and Investigators.
• Assist all aspects of the protocol lifecycle including scientific review, initial investigational new drug (IND) documents, institutional review board (IRB) submission of protocols, continuing review applications, protocol amendments, annual reports to other regulatory and safety bodies such as the Radiation Safety Committee (RSC) and the Institutional Biosafety Committee (IBC), and protocol inactivation
• Prepare submissions for scientific review, institutional review board (IRB) review, investigational new drug (IND)/ Food and Drug Administration (FDA), safety monitoring committees/Data Safety Monitoring (DSMB), and other required committees.
• Prepare and compile data from ongoing protocols and drafts annual continuing review reports for distribution to appropriate regulatory agencies.
• Work with Investigators to ensure Data and Safety Monitoring Board (DSMB), Safety Monitoring Committee (SMC), or other safety reviews are completed in a timely manner.
• Monitor key ethical and legal issues related to protection of research participants, adherence to policies and to Federal and state regulations surrounding the collection, storage, dissemination, and use of biospecimens and data.
• Review documents for content, accuracy, and compliance with applicable regulations prior to submission to regulatory agencies.
• Compile and maintain study essential regulatory document and files (digital and hardcopy) throughout the lifecycle of sponsorship.
• Consult with research nurses, principal investigators, contractors, research sponsors, and regulatory personnel regarding regulatory issues and requirements and protocol adherence and interpretation.
• Perform other duties as assigned.

Requirements

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Conditions of employment

• 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 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.
• Based on your appointment, a one or two-year trial/probationary period may be required. A decision regarding your continued employment with NIH will be made as you near the end of this period.
• Position requires Education. You are strongly encouraged to submit a copy of your transcripts (or a list of your courses included titles, credit hours completed, and grades.

Qualifications

Education Requirement: In order to qualify for a Regulatory Affairs Specialist GS-0601-13 position, you must possess 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).

In addition, to qualify for a Regulatory Affairs Specialist GS-0601 position at the GS-13 grade level, you must have: 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: (1) Leading protocol navigation activities, including coordinating scientific review, Institutional Review Board (IRB) and/or Investigational New Drug (IND) submissions, addressing stipulations, and facilitating clinical trial protocol development processes; (2) Managing a clinical trials portfolio by liaising with investigators/ study teams, regulatory agencies, and sponsors; tracking reviews of all review bodies; and maintaining accurate essential regulatory documentation; (3) Developing regulatory documents such as protocols, consents, and associated components in accordance with federal regulatory requirements; (4) Providing regulatory expertise by analyzing complex issues, preparing safety, annual, and/or progress reports, and recommending strategies to ensure compliance and expedite review processes.

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 or specialized experience from this announcement into your resume as that will not be considered a demonstration of your qualifications for this position.

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:

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.

Additional information

• This position is designated as a "non-emergency/teleworker" position and the selected candidate will be considered a "non-emergency/teleworker" employee. In the event of a closure, you must be available to telework or request leave.
• A newly appointed or reappointed employee may receive service credit for prior work experience or active-duty uniformed service that otherwise would not be creditable for the purpose of determining his or her annual leave accrual rate. All creditable service must be directly related to the duties of the position being filled and decisions to allow for such credit must be finalized prior to the selectee's entrance on duty. Recipients will be determined on a case-by-case basis based on organizational need, specific case justification, and budget limitations.
• At the supervisor's discretion, this position may offer work schedule flexibilities: Alternative Work Schedules.
• PHS Commissioned Officers interested in performing the duties of this position within the Commissioned Corps should apply online to this announcement to receive consideration.
• Visit our Help Applying page for helpful information on the application process.
• If you believe you have a disability (i.e., physical or mental), covered by the Rehabilitation Act of 1973 as amended that would interfere with completing the USA Hire Competency Based Assessments, you will be granted the opportunity to request a RA in your online application. Requests for RA for the USA Hire Competency Based Assessments and appropriate supporting documentation for RA must be received prior to starting the USA Hire Competency Based Assessments. Decisions on requests for RA are made on a case-by-case basis. If you meet the minimum qualifications of the position, after notification of the adjudication of your request, you will receive an email invitation to complete the USA Hire Competency Based Assessments, based on your adjudication decision. You must complete all assessments within 48 hours of receiving the URL to access the USA Hire Competency Based Assessments if you received the link after the close of the announcement. To determine if you need a RA, please review the Procedures for Requesting a Reasonable Accommodation for Online Assessments here: Reasonable Accommodation.
• We may make additional selections for similar positions within the commuting area(s) of the locations listed through this vacancy announcement. By applying, you agree to have your application shared with any interested selecting official(s). Clearance of CTAP/ICTAP will be applied for similar positions.

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Candidates should be committed to improving the efficiency of the Federal government, passionate about the ideals of our American republic, and committed to upholding the rule of law and the United States Constitution.

Benefits

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A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.

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Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.