Ihn Sook Jeong1, Youn Sun Hwang2, Jeong Hee Jeong3, Ji Hyang Youn4. 1. 1 College of Nursing, Pusan National University, Yangsan, South Korea. 2. 2 Department of Nursing, Division of Health Science, Dongseo University, Busan, South Korea. 3. 3 Department of Nursing, Daedong College, Busan, South Korea. 4. 4 Department of Nursing, College of Nursing and Healthcare Sciences, Dong Eui University, Busan, South Korea.
Abstract
BACKGROUND: This study was aimed to examine the number and employment conditions of clinical research coordinators (CRCs) in Korea, with comparison to data from 2010 to identify changes. METHODS: The descriptive study examined 65 sites that participated in a survey or phone interviews among 184 sites registered as clinical trial sites by the Ministry of Food and Drug Safety, and 2 site management organizations. The data were analyzed for mean, standard deviation or median, range, frequency, and percentage. RESULTS: There were 2855 CRCs in 65 sites and 3711 CRCs nationwide, which reflected an increase of 268 people every year on average since 2010. The most common employment system (60.6%) was where CRCs were hired by sites and allocated to clinical trial departments. As for employment type, 48.5% of posts were full-time, and monthly wage payment was the most common at 54.5%. An employment/personnel management department was reported at 87.9% of sites. The average duration from hiring to resignation was 19 months. CONCLUSIONS: The number of CRCs was increased, and such an increase of CRCs was attributed to the increase of investigator-affiliated CRCs rather than site-affiliated CRCs. Though the employment conditions of CRCs have been improved, most improvements were confined to site-affiliated CRCs. It is recommended that each site have a CRC registration and management system for both site-affiliated CRCs and investigator-affiliated CRCs, standardized CRC employment guidelines, and support for CRCs to participate in the training program for the overall improvement of employment conditions of CRCs in Korea.
BACKGROUND: This study was aimed to examine the number and employment conditions of clinical research coordinators (CRCs) in Korea, with comparison to data from 2010 to identify changes. METHODS: The descriptive study examined 65 sites that participated in a survey or phone interviews among 184 sites registered as clinical trial sites by the Ministry of Food and Drug Safety, and 2 site management organizations. The data were analyzed for mean, standard deviation or median, range, frequency, and percentage. RESULTS: There were 2855 CRCs in 65 sites and 3711 CRCs nationwide, which reflected an increase of 268 people every year on average since 2010. The most common employment system (60.6%) was where CRCs were hired by sites and allocated to clinical trial departments. As for employment type, 48.5% of posts were full-time, and monthly wage payment was the most common at 54.5%. An employment/personnel management department was reported at 87.9% of sites. The average duration from hiring to resignation was 19 months. CONCLUSIONS: The number of CRCs was increased, and such an increase of CRCs was attributed to the increase of investigator-affiliated CRCs rather than site-affiliated CRCs. Though the employment conditions of CRCs have been improved, most improvements were confined to site-affiliated CRCs. It is recommended that each site have a CRC registration and management system for both site-affiliated CRCs and investigator-affiliated CRCs, standardized CRC employment guidelines, and support for CRCs to participate in the training program for the overall improvement of employment conditions of CRCs in Korea.
Entities:
Keywords:
clinical research coordinator; employment; personnel management