United States onlyThe 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
