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Job Req ID:  113555

IRB Reliance Coordinator

The Office of Human Subjects Research is seeking an IRB Reliance Coordinator. This position is part of a team that processes human subjects research protocols overseen by the JHM Institutional Review Boards (IRB).


The IRB Reliance Coordinator is responsible for providing administrative support and coordination for the reliance process and relationships between the JHM Human Research Protection Program (HRPP) and outside/external IRBs, including academic and commercial IRBs. Within the scope of the reliance relationships utilizing the single IRB (sIRB) model, JHM participates as both a relying IRB and reviewing IRB. This position will provide technical and administrative support for reviews conducted under the reliance process.


This position has been designated as a 100% remote position. On-site attendance may be required for select meetings or events. Advanced notice will be provided for these circumstances.


Specific Duties & Responsibilities

  • Demonstrates knowledge-based understanding of the complete IRB review process.
  • Works with minimum supervision to provide administrative support and advice regarding human subject's research applications submitted to the IRB, with a specific focus on submissions subject to a reliance agreement.
  • Triages inquiries submitted through the IRB Reliance email inbox and the online reliance request tool and provides consultation to JHM investigators inquiring about the reliance agreement process.
  • Conducts administrative review of designated human subjects research application submissions including verification of training requirements related to sIRB review.
  • Determines level of review appropriate for research submissions.
  • Advises & assists investigators and their staff [both internal and external to the institution] regarding submission of applications in accordance with institutional policy, federal, state, and local regulations governing human subject's research.
  • Formulates agenda materials and tracks components of the review process, including communication with other offices and committees.
  • Processes documents related to sIRB review including relying on site materials and consent documents.
  • Independently prepares appropriate correspondence to document the IRB’s decision regarding the review of human subject's research applications.
  • Maintains a working knowledge of JHM IRB procedures, guidelines and policies for all research, and research subject to review under an IRB reliance agreement.
  • Assists in communicating cede determinations to JHU and external investigators for studies where JHM IRB is the reviewing IRB or a relying institution.
  • Tracks reliance agreements and associated letters of indemnification when JHM IRB is the reviewing IRB or relying on an external IRB.


Special Knowledge, Skills and Abilities

  • Good analytical and writing skills.
  • Knowledge of the ethical principles and regulations relevant to human subject's research and IRB processes.
  • Demonstrated ability to work independently, exercise sound judgment and multi-task.
  • Ability to communicate in a professional, positive and persuasive manner.
  • Strong administrative/coordination skills.
  • Experience in high volume office and ability to meet time sensitive processing deadlines.


Physical Requirements

  • Sitting in a normal seated position for extended periods of time.
  • Reaching by extending hand(s) or arm(s) in any direction.
  • Finger dexterity is required to manipulate objects with fingers rather than with whole hand(s) or arm(s), for example, using a keyboard.
  • Communication skills using the spoken word.
  • Ability to see within normal parameters.
  • Ability to hear within normal range.
  • Ability to move about, including transportation of a laptop computer and files.

*This description is a general statement of required major duties and responsibilities performed on a regular and continuous basis. It does not exclude other duties as assigned.



Minimum Qualifications
  • Bachelor's Degree.
  • A minimum of two years of related human subject's protections and/or research administrative experience are required.
  • Graduate level education and training may substitute for up to one year required experience, to the extent permitted by the JHU equivalency formula.


Preferred Qualifications
  • Direct experience working within an IRB office is preferred.

 

 

Classified Title: IRB Coordinator 
Job Posting Title (Working Title): IRB Reliance Coordinator   
Role/Level/Range: ATO 40/E/03/OF  
Starting Salary Range: $21.00 - $36.50 HRLY ($54,600 targeted; Commensurate with experience) 
Employee group: Full Time 
Schedule: Monday - Friday 8:30am - 5:00pm 
Exempt Status: Non-Exempt 
Location: Remote 
Department name: ​​​​​​​SOM Admin Clinical Invest Human Subjects  
Personnel area: School of Medicine 

 

 

Total Rewards
The referenced salary range is based on Johns Hopkins University’s good faith belief at the time of posting. Actual compensation may vary based on factors such as geographic location, work experience, market conditions, education/training and skill level. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/.

Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines: JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.

**Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.

The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.

The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion.

Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

EEO is the Law:
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf

Accommodation Information
If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the Talent Acquisition Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit https://accessibility.jhu.edu/.

Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. The COVID-19 vaccine does not apply to positions located in the State of Florida. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/ and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/.

The following additional provisions may apply, depending upon campus. Your recruiter will advise accordingly.

The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
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