What is it about?
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. 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.
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Why is it important?
This study is meaningful since it establishes the changes over the last 7 years in the number and employment conditions of CRCs in Korea. 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.
Perspectives
The study sought to identify changes in CRC employment conditions and provide evidence of appropriate strategies for CRC personnel management. I look forward to the best standards for CRC qualification, compensation and manpower management in the future considering employment policies and circumstances in Korea.
Youn Sun Hwang
Dongseo University
Read the Original
This page is a summary of: Changes in the Number and Employment Conditions of Clinical Research Coordinators in South Korea, Therapeutic Innovation & Regulatory Science, October 2018, SAGE Publications,
DOI: 10.1177/2168479018803093.
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Resources
Role Performance and Related Factors of the Clinical Research Coordinator
Purpose: The purpose of this study was to analyze the role performance and related factors of the Clinical Research Coordinator (CRC). Methods: A quantitative, cross-sectional design was used. Data were collected using a structured questionnaire from 134 Clinical Research Coordinators in 4 hospitals and analyzed using descriptive statistics, t-test, ANOVA, and Pearson correlation coefficient. Results: The scores for role performance of CRC were high (average 336.51 points of a possible 420 points, mean average 5.74±0.67 of a possible 7) and the degree of role performance in the management task sub dimension (mean average 6.12±0.77 of a possible 7) was higher than any other sub dimension. Role performance of the CRC was also related to job satisfaction (r=.198, p=.023). Conclusion: The study results indicate that most CRC are nurses and perceive their role as very important. Further the CRC performance of activities of management task and the Coordination/Advocacy task sub dimension were high and higher levels of job satisfaction were related to higher levels of role performance of CRC was. Therefore, strategies related to improvement in the fringe benefit system and work environment should be developed to increase job satisfaction and thus increase job performance.
Comparison of the Perceptions between Investigators and Clinical Research Associates in Role Performances of Clinical Research Coordinators
The aim of this study was to compare the perceptions of the role performance of a clinical research coordinator (CRC) between the investigators and clinical research associates (CRAs). Data was collected using a structured questionnaire from 39 investigators and 68 CRAs in 4 hospitals from March 7 to November 30, 2011 and analyzed using descriptive statistics and a t-test. The investigators and CRAs were aware of the importance of CRC`s role and they all gave the highest values for patients care management. On the other hand, the score of the role performance items showed perceptional differences between investigators and CRAs. Therefore, the development of detailed job descriptions and manuals will be needed to reduce the perceptional differences in the role performance of the CRC.
Current Status of Clinical Research Coordinator's Employment
Background: This study was aimed to investigate the current two years' clinical research coordinators (CRCs) employment and estimate total number of CRCs in Korea. Methods: The participants were administrative officers or head CRCs in institutions designated by Korea Food & Drug Administration (KFDA). Data on the current status of CRCs' employment was collected with self-administered questionnaires or telephone interview. And total number of CRCs in Korea was estimated based on ratio between the number of the KFDA approved clinical trials and current number of CRCs. Results: The number of CRCs was 1381 at 36 centers in 2009 and 1444 at 37 centers in 2010. About 79 percent of CRCs were employed by investigators. The estimated number of CRCs was from 1677 to 1763 at 135 centers in 2009 and from 1802 to 1890 at 142 centers in 2010 based on number of clinical trials approved by KFDA. Two third of regional clinical trial centers (RCTCs) had written employment policy, and 25 percent of RCTCs employed CRCs in a regular position. All RCTCs had educational programs for CRCs and supported CRCs for training outside. 75 percent of RCTCs provided ID card for CRCs belonging to investigators to access to hospital document. Half of RCTCs had CRC registration system in hospital-wide. Conclusion: The number of CRCs in Korea can be easily estimated with the number of KFDA approved clinical trials. Majority of RCTCs still employed CRCs in an irregular position, which should be switched to regular position to reduce the CRCs' unsatisfaction. It is also needed to develop centralized CRC management system for CRCs belonging to investigators.
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