What are the responsibilities and job description for the Regulatory Affairs Specialist position at National Institutes of Health?
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: https://apply.usastaffing.gov/ViewQuestionnaire/12966441
Responsibilities:
- 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.
Salary : $121,785