Essential Duties: Under general direction services as the primary regulatory resource for investigators and staff. Primary coordination responsibilities include dissemination of information about and assistance to investigators in the preparation of IRB applications. The position coordinates the preparation of applications for presentation to the IRBs and will independently determine the adequacy of the application and the level of review required (exempt, expedited, full board).
* Screen new and renewable applications; contact and advice investigators in preparation and completion of application process * Prepare meeting agendas, assigns applications to IRB committee(s)
* Prepares IRB member packets and distributes them prior to the IRB meeting. * Maintains study annual renewal system to include preparation of tickler reports
* Preparation and dissemination of reminders and appropriate forms, advises investigators and staff as required. * Closes out study applications to include appropriate forms and preparation of files for final reports for closure * Prepares study withdrawal applications when required * Prepares and finalizes applications to include filing * Prepare IRB meeting minutes * Prepares and distributes IRB meeting approval, renewal, termination, and contingent approval letters. * Assist other coordinators when necessary with similar duties * Handles general office procedures (filing, answering and responding to telephone calls, copying, etc.)
* Bachelor's Degree
* Two -- Three (2-3) years of experience; preferably in a medical related field. This position requires a flexible person with experience in IRB review, skilled in interpersonal relationships and able to deal with high volume and rigid deadlines.