Classified Title: IRB Coordinator
Working Title: IRB Reliance Coodrinator
Role/Level/Range: ATO 40/E/03/OF
Starting Salary Range: $19.62 - $27.00
Employee group: Full Time
Schedule: M-F 8:30 am - 5:00 pm
Exempt Status: Non-Exempt
Location: 1620 McElderry St
Department name: 10002712-SOM Admin Clinical Invest Human Subjects
Personnel area: School of Medicine
The IRB Reliance Coordinator is part of a team that processes human subjects research protocols overseen by the JHM IRB. The IRB Reliance Coordinator is responsible for providing administrative support and coordination for the reliance process and relationships between the JHM HRPP and outside/external IRBs, including institutional 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 protocol technical and administrative support for reviews conducted under the reliance process.
Duties & Responsibilities
- 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.
- Provides phone and in-person consultation to JHM investigators inquiring about the reliance agreement process.
- Triages inquiries submitted through the general IRB Reliance email inbox and the reliance request tool.
- 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.
- Records IRB meeting minutes in keeping with current policies and procedures. Must be able to accurately and succinctly summarize discussions regarding scientific and regulatory matters pertaining to human subjects research.
- 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.
- Serves as a JHM IRB liaison for external reliance platforms where reliance determinations may be documented.
- Tracks reliance agreements and associated letters of indemnification when JHM IRB is the reviewing IRB or relying on an external IRB.
- Supports JHM IRB staff and member time tracking for time spent on IRB reliance activities.
- With the Assistant Dean, Director of Operations. IRB Reliance Manager, Systems Administrator and others, work with Research Environment Systems (RES) to make improvements to the relevant electronic application submission system(s) to enable processing of submissions where JHM IRB is serving as the single IRB or relying on external IRBs.
- With the Training Specialist and others, provide training and education for PIs, study teams, IRB members and others on the IRB reliance process.
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 IRB Reliance Manager.
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.
Special knowledge, skills, and abilities
- 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.
- Sitting in a normal seated position for extended periods of time.
- Reaching by extending hand(s) or arm(s) in any direction.
- Finger dexterity 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.
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 email@example.com. 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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