| Job Description: |
Non-FB functions:
• Evaluate certain types of IRB submissions: pre-review of new studies, revisions, continuing reviews reportable events, ceded submissions, and tabled submissions.
• On the basis of IRB Executive reviewers’ comments in myIRB, accurately generate communication to the principal investigators that report the results of the IRB Expedited review. This includes ‘needs reply’, ‘approved with contingencies’, suspensions, and other letters.
• Assist faculty to prepare protocols for IRB review. Evaluate each aspect of the protocol, including the SmartFOrms, IRB Protocol, Informed Consent Forms, and Revisions, provide technical assistance in the development of these proposals and in the multitude of revisions, renewals, and adverse event reports that are submitted. The employee interacts with faculty, staff, students, Department Chairs, Deans, and Directors to resolve any problems or errors, which may result from the review. Serve as a new investigator liaison.
Coordinate pre-review by:
• Inbox distribution
• Creates pre-review training materials and formalizes pre-review SOPs
Leads myIRB functional team testing and directs educational efforts
Board Meeting preparation functions include:
• Analyze and evaluate proposals to ensure that proposals meet agency, federal, state, and university guidelines in preparation for Committee review.
• Review agenda items, board member attendance and prepare overhead and template language for minutes.
Correspondence:
• Generate some letters of approval and serve as a back-up for other IRB office staff as needed.
• Listserv management
• Appointed as an office board member/contingency approver, approve contingencies in accordance with office guidelines.
• Assist in revising/creating office documents as needed
Other duties as assigned
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