Initial Education for CRCs with Different Background Knowledge: Case study of a company supporting clinical trials in Fukuoka, Japan

Abstract

The purpose of this paper is to examine the curriculum requirements for the development of clinical research coordinators (CRCs). In particular, the purpose of this paper is to examine and clarify what kind of effect their prior knowledge and skills had in acquiring the basic knowledge and skills of CRCs when they landed this profession. Clinical trials on human subjects are trials to test the efficacy and safety of drug candidates (hereafter referred to as investigational drugs). CRCs come from a variety of backgrounds, including licensed nurses, licensed laboratory technicians, and non-medically qualified personnel. Companies must provide initial and ongoing education to CRCs to ensure they become an asset in the company. However, there is no uniform training curriculum in the industry to date, as each company is providing its own training to CRCs. In this study, we conducted in-depth interviews with six CRCs at Company F in Fukuoka, Japan, including three new CRCs (one CRC a certified laboratory technician, one CRC a certified nurse and one CRC without a medical license). In addition, CRCs’ work practices were conducted by participant observation to examine what kind of initial education is needed for CRCs with different backgrounds, in line with the qualitative data.

Keywords: Clinical Research Coordinators (Crcs), Initial Education, Participant Observation

DOI: 10.54941/ahfe1005106