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Job Responsibilities:

The Research Compliance IRB Analyst I are primarily responsible for the management of a caseload of applications received for IRB review, performing a detailed analysis of all applications submitted. The IRB Analyst is a primary point of contact with the research community.

• Maintains responsibility for protocols submitted for IRB review, demonstrating an ability to learn and apply the principles and regulations related to human subject research
• Performs pre-committee analysis of protocols confirming completeness and compliance with regulations and IRB policies; determines the most expeditious processing mechanism allowed for an application and recommending this method to IRB reviewers; attends IRB meetings and provides technical support and guidance on regulatory matters; writes comprehensive meeting minutes outlining the ethical and medical issues analyzed by the committee; and accurately documents the final determinations of the IRB.
• Composes clear, concise and detailed correspondence to investigators to ensure that the concerns, rationale, and technical questions of the IRB are quickly and intelligibly communicated to the researchers; conducting staff evaluation of investigator?s response to identify potential issues for IRB reviewers; issuing approval documents; and maintaining accurate updates in the Departmental online submission and tracking system.
• Advises investigators and research staff on federal regulations and IRB submission requirements and assisting them, as needed, in the preparation of IRB submissions, consent form drafts and/or responses to IRB correspondence
• Participates, as requested, in departmental quality improvement activities by identifying needs in department operations and making recommendations for their improvement, focusing on continued improvement of the Departmental online submission and tracking application, workflow and activities related to IRB processing; and assisting with other special projects as assigned.

Educational Requirements:

Bachelor?s degree in Humanities or Sciences related field required.

License/Certification Requirements:

Certified Institutional Review Board (IRB) Professional Certification, preferred.

Experience:

2 years experience working in a Business office offering exposure to MS office Suite, Email communications, and Online Tools, required.

1 year experience of Clinical Research Experience, preferred.

Physical Demands:

Walking, sitting, standing. Primary duties require computer work.