Lauren E Ballina
Clinical Research Fastrack, USA
Title: Re-inventing the Entry-Level Clinical Research Coordinator
Biography
Biography: Lauren E Ballina
Abstract
The varying level of knowledge, competency, and professionalism of clinical research coordinators at the site level is problematic in clinical research. The role of clinical research coordinator (CRC) is a technical position requiring working knowledge of ICH GCP and the Code of Federal Regulations. CRCs are required to collect and document data appropriately and accurately. Their work can have direct impact on the efficiency and quality of a trial. Of 60 current clinical research professionals surveyed, 4 (7%) reported purposefully seeking a position in clinical research. The remaining 56 reported that they “fell into clinical research” and stayed because the field is so rewarding. All reported on the job training in their entry-level position as inconsistent and incomplete. Many felt overwhelmed in their first position and that experience and mistakes have been their best teachers.
Clinical Research Fastrack (CRF) has sought to standardize entry-level training for CRCs. By delivering a robust curriculum focused on ICH GCP, Code of Federal Regulations, protocol, good documentation practices, adverse events, protocol deviations, clinical trial operations, participant recruitment and retention, responsibilities of study team members including PI, informed consent, and research skills all coupled with a hands-on internship at a clinical trial site, CRF is re-inventing the entry-level CRC. Through training standardization, and utilizing an innovative educational approach of “massed practice” CRF is helping transform the role of coordinator to a profession and not just a job. As more well-trained individuals obtain positions in the field, the industry as a whole will benefit.