Job Posting: Regulatory Affairs Specialist
Summary
If you are an experienced Regulatory Affairs Specialist and you want to play a significant role in a dynamic organization, then consider joining the National Institutes of Health!
Duties
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.
Who Can Apply
Veterans
Veterans of the U.S. Armed Forces.
Special authorities
Individuals eligible under a special authority not listed above, but defined in the federal hiring regulations.
Peace Corps & AmeriCorps Vista
Individuals who have served at least 2 years with the Peace Corps or 1 year with AmeriCorps VISTA.
Family of overseas employees
Family members of a federal employee or uniformed service member who is, or was, working overseas.
Military spouses
Military spouses relocating under PCS orders, or whose spouse is 100% disabled or died while on active duty.
Land & base management
Certain current or former term or temporary federal employees of a land or base management agency.
Career transition (CTAP, ICTAP, RPL)
Federal employees who meet the definition of a "surplus" or "displaced" employee.
Federal employees - Competitive service
Current or former competitive service federal employees.
Individuals with disabilities
Individuals who are eligible under Schedule A.
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