Leanne Kierstead, Capm Email & Phone Number

Raleigh, North Carolina

Responsible for the distribution, completion, execution, and maintenance of Regulatory Documents for each research study. Collaborates with the sponsor regulatory contact to ensure that regulatory documents are completed in an organized and timely matter to maintain study-startup timelines. Makes changes to any regulatory documents as needed until completion of study. Responsible for Initial Site Submission for Principal Investigator to Institutional Review Board. Submits any changes that need to be made to informed consent form. Responsible for management of IRB portals and distribute updated documents to site staff. Submits status reports and closeout reports to the IRB with the assistance of the study coordinator.

At Wake Research I rotated through Clinical and Recruitment departments, shadowing coordinators and recruiters. I have also been involved in cataloging and organizing regulatory and source documents for off-site recall. As new studies have been introduced I have attended study specific meetings, as well as assisted coordinators with daily activities.