Clinical expertise has a clearly defined role and purpose in clinical research from randomizing treatments to managing adverse events to monitoring the overall health of participants. However, scientific expertise seems to be expected only from those who design studies, analyze final datasets, and manage the investigational products in question. This increases a sense of separation between sponsors and sites that results in clinical trial operations being considered mostly in terms of financial transactions. At the site level, a similar divide in research staff often occurs as the study coordinators understand the study mechanics and the medical clinicians understand the disease, often causing friction in operations and staff turnover. By developing a novel clinical research model, our team has addressed these gaps and witnessed improvements in staff recruitment and retention as well as decreases in detrimental protocol deviations. This model includes a clear career development pathway for clinical research professionals.

CEU: 1.00 ACRP

Speaker:

• Lacey Andrews, MS, CCRC, CCRA, Lead Clinical Research Coordinator, Marshall University's Joan C. Edwards School of Medicine, Department of Family and Community Health

• Todd Davies, PhD, Associate Director of Research, Marshall Health