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IRB Reliance Administrator University Administration 53208BR
The IRB Reliance Administrator is part of a team that processes human subjects research protocols overseen by the Harvard University Area (HUA) IRB. The IRB Reliance Coordinator position includes several duties but is primarily responsible for leading the reliance process and negotiating relationships between HUA IRB and outside/external IRBs, including institutional and commercial IRBs. Within the scope of the reliance relationships utilizing the single IRB (sIRB) model, HUA participates as both a relying IRB and reviewing IRB.
The IRB Reliance Coordinator is responsible for carrying a moderate portfolio of IRB reviews as well as administrative support for the convened IRB including the preparation of the IRB meeting agenda and IRB meeting minutes.
The IRB Reliance Administrator will assist the Director to develop, implement, and manage the Quality Assessment and Quality Improvement (QA/QI) Program for the Human Research Protection Program.
He/she will report to the Director of the Harvard University-Area IRB office with an indirect reporting line to the Director of IRB Administration.
Demonstrates a knowledge-based understanding of the complete IRB review process.
Works independently to lead and offer guidance regarding human subjects research applications submitted to the IRB, with a specific focus on submissions subject to a reliance agreement.
Consults via phone and in-person with HUA 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.
Maintains a working knowledge of HUA IRB procedures, guidelines, and policies for all research, and research subject to review under an IRB reliance agreement.
Communicates cede determinations to HUA and external investigators for studies where HUA IRB is the reviewing IRB or a relying institution.
Serves as a HUA IRB liaison for external reliance platforms where reliance determinations may be documented.
Tracks reliance agreements when HUA IRB is the reviewing IRB or relying on an external IRB.
Determines level of review appropriate for research submissions.
Basic Qualifications Candidates MUST meet the following basic qualifications in order to be considered for this role:
Bachelor's degree with at least 2 -years of experience related to the field of human subjects research protections.
Demonstrated knowledge and understanding of the federal regulations on human research protections.
Demonstrated proficiency in the MS-Office Suite of computer applications.