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Remote Institutional Review Board Jobs (NOW HIRING)

We are seeking a candidate experienced with regulatory compliance and institutional review boards ... This position will have the potential for a remote work arrangement based on operational needs and ...

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Remote Institutional Review Board information

What are some common challenges faced by remote Institutional Review Board (IRB) members, and how can they be addressed?

Remote IRB members often face challenges such as coordinating meetings across different time zones, maintaining effective communication with fellow board members, and ensuring data security during the review of sensitive documents. To address these challenges, many organizations utilize secure online platforms for document sharing and videoconferencing, establish clear protocols for communication, and schedule meetings well in advance to accommodate diverse schedules. Developing strong digital collaboration skills and staying updated on evolving regulations are also key to success in a remote IRB role.

What is a Remote Institutional Review Board (IRB)?

A Remote Institutional Review Board (IRB) is a committee that reviews and oversees research involving human subjects to ensure ethical standards are met, but operates virtually rather than in a traditional in-person setting. These remote IRBs use online platforms and digital tools to review study protocols, communicate with researchers, and monitor compliance with regulations. This approach allows for flexibility, wider geographic participation, and faster decision-making while still upholding the rigorous ethical and legal requirements set by federal and institutional policies.

What are the key skills and qualifications needed to thrive as a Remote Institutional Review Board (IRB) Member, and why are they important?

To thrive as a Remote Institutional Review Board Member, you need a solid understanding of research ethics, regulatory compliance (such as 45 CFR 46), and typically a background in research, healthcare, or law. Familiarity with IRB management software, online meeting tools, and relevant federal or institutional compliance systems is common. Strong analytical thinking, attention to detail, and effective communication are crucial soft skills for reviewing protocols and collaborating remotely. These skills ensure ethical oversight, participant safety, and regulatory adherence in human subjects research conducted in distributed environments.

What is the difference between Remote Institutional Review Board vs Remote Clinical Research Coordinator?

AspectRemote Institutional Review BoardRemote Clinical Research Coordinator
Required CredentialsIRB certification, research ethics trainingClinical research training, sometimes IRB knowledge
Work EnvironmentReview boards, ethical oversight, administrativeParticipant coordination, data management, site communication
Employer & Industry UsageHospitals, research institutions, biotech firmsPharmaceutical companies, research sites, CROs

The Remote Institutional Review Board primarily focuses on ethical review and approval of research protocols, requiring knowledge of research ethics and IRB certifications. In contrast, the Remote Clinical Research Coordinator manages study logistics, participant interactions, and data collection. While both roles support clinical research, the IRB role emphasizes oversight and compliance, whereas the coordinator handles day-to-day study operations.

More about Remote Institutional Review Board jobs
What cities are hiring for Remote Institutional Review Board jobs? Cities with the most Remote Institutional Review Board job openings:
What are the most commonly searched types of Institutional Review Board jobs? The most popular types of Institutional Review Board jobs are:
What states have the most Remote Institutional Review Board jobs? States with the most job openings for Remote Institutional Review Board jobs include:
Infographic showing various Remote Institutional Review Board job openings in the United States as of May 2026, with employment types broken down into 55% Full Time, 22% Part Time, 6% Temporary, and 17% Contract. Highlights an 100% Remote job distribution.
Regulatory Affairs Specialist

Regulatory Affairs Specialist

National Institutes of Health

MD • On-site, Remote

$121K - $158K/yr

Full-time

PTO

Posted 5 days ago


National Eye Institute rating

7.3

Company rating: 7.3 out of 10

Based on 5 frontline employees who took The Breakroom Quiz

44th of 57 rated research


Job description

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!
Learn more about this agency
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 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.
  • 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: https://apply.usastaffing.gov/ViewQuestionnaire/12966441
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.
Review our benefits
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.