J Korean Soc Clin Pharmacol Ther.  2011 Jun;19(1):40-51.

Current Status of Clinical Research Coordinator's Employment

Affiliations
  • 1College of Nursing, Pusan National University, Korea. jeongis@pusan.ac.kr
  • 2Clinical Trial Center, Pusan National University Yangsan Hospital, Korea.
  • 3Department of Pharmacology, Inje University College of Medicine and Department of Clinical Pharmacology, Busan Paik Hospital, Korea.
  • 4College of Nursing Science, Kyunghee University, Korea.

Abstract

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.

Keyword

Employment; Clinical research coordinator

MeSH Terms

Calcium Hydroxide
Employment
Head
Humans
Interviews as Topic
Korea
Surveys and Questionnaires
Research Personnel
Zinc Oxide
Calcium Hydroxide
Zinc Oxide
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