The IRB Reliance Coordinator 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.
Essential Job Functions
Demonstrates knowledge-based understanding of the complete IRB review process.
Works with minimum supervision to provide administrative support and advice regarding human subjects 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 subjects 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 site materials and consent documents.
Independently prepares appropriate correspondence to document the IRB's decision regarding the review of human subjects 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.
Scope of Responsibility
The IRB Reliance Coordinator must be able to make sound judgements and take responsibility for independent decisions and actions while following regulatory criteria.
The IRB Reliance Coordinator reports to the Associate Director, IRB Reliance Program.
The IRB Reliance Coordinator must have excellent written and verbal communication skills. The coordinator must have the ability to work as a team member, be very detailed oriented, and communicate with faculty and staff both internal and external to the institution at all levels.
Bachelor's degree required. Graduate level training can substitute for up to one year of related experience as described below.
A minimum of two years of related human subjects protections and/or research administrative experience are required. Direct experience working within an IRB office preferred.
Good analytical and writing skills.
Knowledge of the ethical principles and regulations relevant to human subjects 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.
Classified Title: IRB Coordinator Working Title: IRB Reliance Coordinator Role/Level/Range: ATO 40/E/03/OF Starting Salary Range: $19.82 - $27.27 Employee group: Full Time Schedule: M-F 8:30 - 5:00 Exempt Status: Non-Exempt Location: 04-MD:School of Medicine Campus Department name: 10002712-SOM Admin Clinical Invest Human Subjects Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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 HR Business Services Office at firstname.lastname@example.org. For TTY users, call via Maryland Relay or dial 711.
The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.
During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.
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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