Qualifications of the Research Staff

Abstract

Through the use of clinical trials, the global research community have paved the way for new medical interventions and ground breaking new therapies for patients. In the past 60 years we have embraced rigorous scientific standards for assessing and improving our therapeutic knowledge and practice. These scientific standards dictate that a research workforce possessing knowledge, skills, and abilities is crucial to the success of a study. The many challenging (and ever changing) rules and regulations inherent in the clinical research arena also require diligent trained staff be available to conduct the study. While it is well known that the Principal Investigator is ultimately responsible for the conduct of the study, it is generally a team of individuals who conduct the daily operations of the study. This chapter discusses qualifications and training of other research staff members and why these are important for achieving success in clinical trials.