The George Mason University Research Development, Integrity and Assurance (RDIA) office invites applications for a Senior IRB (Institutional Review Board) Compliance Specialist.
The primary responsibilities of the Senior IRB Compliance Specialist include the following:
1) performing analysis of protocols to review for completeness and compliance with regulations and IRB policies and procedures;
2) determining whether the protocol constitutes human subjects research, assigning the appropriate category under federal guidelines and
3) either performing the evaluation, sending the protocol to a board member for expedited review, or recommending that it be reviewed by the full board.
The Senior IRB Compliance Specialist determines the most expeditious processing mechanism allowed for an application based on an understanding of the proposed research and an interpretation of appropriate guidelines. In addition, the Senior IRB Compliance Specialist attends monthly IRB meetings and provides technical support and guidance on regulatory matters; writes highly detailed meeting minutes to outline the issues analyzed by the committee, and accurately documents the final determinations of the IRB. The Senior IRB Compliance Specialist also 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; conducts evaluation of investigator’s response to identify potential issues for IRB reviewers; determines when IRB requirements for approval have been met and issues approval documents. The Senior IRB Specialist maintains accurate electronic IRB files; assists in creating meeting agendas and with meeting material preparation; meets with investigators and research staff to advise them on federal regulations and IRB submission requirements and assists them as needed in the preparation of submission forms; and conducts educational IRB classroom presentations as needed.