PRINCIPAL DUTIES:
• Conducts screening (pre-review) of submissions to the !RB and determine if the submissions include adequate information for review and determine the level of review required. Makes recommendations to eliminate problems before submissions are forwarded for expedited or convened review. Gathers information and background material in response to inquiri raised and responds to requests for information regarding lRB review
• Reviews exempt project proposals and may serve as designated reviewer for expedited projects when deemed appropriate by the IRB
Chairperson,; reviews Reportable New Information reports; and makes non-human subject research determinations.
• Disseminates information about and assist investigators in the preparation of IRB applications to ensure that required elements are
addressed and that all documents are prepared in accordance with appropriate standards.
• Knows the expertise of IRB committee members in order to make appropriate assignments for review, ensure that reviewers
complete necessary reviewer checklists promptly.
• Coordinates IRB meetings, contributes to agendas and minutes, ensures submission packages are distributed and reviewed promptly,
reviews materials with IRB chairperson, monitors existing, and new protocols to ensure compliance with National Committee on
Biomedical Ethics (NCBE) and Human Research Protection Administration (HRPA) requirements.
• Coordinates special projects identified and assigned by IRB officials. Assists with revisions and implementation of IRB forms, policies,
and standard operating procedures. Assists in identifying areas of focus for education topics and performs worksho for
the hospital community on lRB policies and procedures. Assists in education initiatives and attends workshops and conferences
focused on current issues affecting the IRB oversight of the protection of human subjects in research. Informs IRB officials of issues raised by the IRB or investigators.
• Maintains confidentiality relating to all matters dealt within the department. Uses great discretion at all times and ensure that no
confidential material is leaked from the department to unauthorized members of staff.
• Follows all hospital-related policies and procedures. Participates in emergency and disaster procedures. Performs other duties within
the realm of h knowledge and ability as required.
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