Provides secondary administrative and primary clerical support for the Institutional Review Board (IRB), a committee made up of faculty at the institution that is responsible for the review and oversight of human subjects protection. Federal law and/or guidelines from the Public Health Service define the IRBs charge, purview, and many of their activities.
Familiarity with the federal regulations in order to maker sure that clerical duties comply with guidelines and the law. Works in close collaboration with the IRB Administrator to assure that all records and documentation related to IRB activity are complete, accurate and appropriate.
Assist the IRB Administrator in receiving incoming protocols for the monthly meeting. This includes a screening of the submissions for completeness and accuracy and potentially contacting individuals to bring that process to closure. The IRB receives, on average, 20 new protocols for full Board review per month. This activity is deadline driven and must be accomplished quickly yet thoroughly.
Assist the IRB Administrator in the collation, assignment, and distribution of new protocols for review.
Production of the agenda for monthly meetings of the IRB. This entails working with the IRB Administrator to compile and list all administrative activities of the IRB Office for the month. This document usually ranges form 10-15 pages long and must reliably be complete and accurate as it is subject to audit. This process takes place over the entire month, but is deadline driven around the monthly submission deadline since it must be distributed to IRB members in a timely manner.
Assist in communications for the IRB including verbal and written communications between faculty and the committee, the Chair and the committee, the committee and the Dean for Research, and others.
Responsible for managing the review and correspondence surrounding adverse event reports. This includes the receipt of adverse event reports, both local and non-local, their preparation for review by committee members, scheduling of physician committee members to come to the IRB Office and review those reports, and production of all correspondence out of the IRB Office related to these reports.
Responsible for the administration of the continuing review process for active IRB protocols. This is a critical part of compliance with federal regulation as continuing review is necessary for approval of protocols on a yearly basis. The IRB manages between 5-700 active protocols annually and a database is utilized to assist in this effort. In addition, a continual audit of the active files is necessary. The basic components of the process include: 1) monitoring the database and files regularly to ascertain progress report due dates; 2) providing reminder correspondence to faculty that their progress reports are due; 3) receipt, screening, and administrative preparation of submitted progress reports for review by IRB members; 4) all communications (verbal and written) required as a result of that review, whether notification of approval or if information needs to be amended or added to complete the review process; 5) production of an addendum agenda for the IRB meeting as needed to assure that all progress reports get to the meeting.
Manage the closeout reports and the transition of files from “active” to the IRB archives, where they are held for five years. Closeout reports, which terminate protocols, are handled similarly to progress reports except that an approval for continuation is not relevant. This process includes entering protocols into the archival database, numbering and packing the files and taking them to the archival storage area.
Responsible for data entry into a shared database of progress reports, closeouts, and adverse events. All other data entry functions are the responsibility of the IRB Administrator. The administrator may, on occasion, request assistance form the IRB secretary for other data entry purposes.
Manage scheduling and logistics of the IRB meeting including the room scheduling and catering. Assist the Administrator in assuring that all materials needed for the meeting are transferred to the meeting place and that all materials are returned to the office.
Attend the IRB meetings along with other office staff and assist in the documentation of discussion using a lap top computer.
Assist in meetings, workshops, or other educational activities related to the regulatory and basic functional aspects of the IRB.
Performs other duties as assigned.
High school diploma plus three years of administrative support experience.