The regulatory and business roles of a Study Director

Abstract

The role of Study Director can be a challenging one with technical, administrative, and compliance responsibilities. The Study Director often does not have direct responsibility for personnel and other resources required for his/her studies. In this article, we have attempted to identify traits and mechanisms to help the Study Director do his/her job in a professional and compliant manner. In addition to regulatory and scientific expertise, Study Director quality attributes include possession of appropriate soft skills and character traits and are key to the success of a study. Study Directors must have an aptitude for effective communication, relationship building, training, mentoring, and delegation. While these soft skills/desirable traits often require additional effort on the part of the Study Director, they have a large impact on the rate of success, efficiency, and compliance of the study overall. The workshop presented by the authors took a 'hands-on' approach building on the creativity, and experience of Study Directors, supervisors, managers, and Quality Assurance (QA) personnel who participated. The participants deliberated problem scenarios from a Study Director's perspective. The tables and discussion in this article summarize compliant solutions, which arose from the resourcefulness that comes from experience of the participants. Copyright © 2005 John Wiley & Sons, Ltd.