The Role of Clinical Research Nurses at Regional Clinical Trials Centers

Seon Ju Do

doi:10.11111/jkana.2010.16.3.348

Journal List > J Korean Acad Nurs Adm > v.16(3) > 1051557

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Do: The Role of Clinical Research Nurses at Regional Clinical Trials Centers

Original Article

Journal of Korean Academy of Nursing Administration

Journal of Korean Academy of Nursing Administration 2010; 16(3): 348-359.

Published online: 30 September 2010

DOI: https://doi.org/10.11111/jkana.2010.16.3.348

The Role of Clinical Research Nurses at Regional Clinical Trials Centers

Seon Ju Do¹

¹Medical Department, Janssen Korea, Seoul, Korea.

Correspondence: Do, SeonJu, Medical Department, Janssen Koream LS Yongsan Tower, Hangangno 2-ga, Yongsan-gu, Seoul 140-702, Korea. CP.: 82-11-9577-3100, dooo80@snu.ac.kr

Received 15 September 2010 Revised 27 September 2010 Accepted 28 September 2010

Abstract

Purpose

This study aimed to evaluate the performance of Clinical Research Nurses (CRNs) and the importance of their roles at the Regional Clinical Trial Centers (RCTCs).

Method

A questionnaire focused on the role of CRNs was crafted by a researcher and the content validity was verified by a panel of experts on clinical research. The subjects of this study were 91 CRNs and Clinical Research Coordinators (CRCs), who were Korean registered nurses working at nine RCTCs. 77 subjects yielded valid data were analyzed using descriptive analysis, the Mann-Whitney U test, Spearman's rank order correlation coefficient, and Kruskal-Wallis test.

Results

The performance of CRNs and the recognition in the importance of their roles were statistically significant different in age, education, CRN careers, positions, employment status and the phase of clinical trial. The role of direct caregiver was performed most often by CRNs. The role of coordinator of care and research (pre-study) was considered the most important role but performed the least frequent.

Conclusions

The role of CRNs can easily be differentiated from CRCs who are not registered nurses. The domains of CRNs should be clearly identified and established. Moreover, research should be carried out on CRN training programs to cultivate competence in CRNs.

Keywords: Clinical Research Nurse, Clinical Trial, Role

Figures and Tables

Table 1

The general characteristics of the experts (N=9)

Table 2

The characteristics of the Regional Clinical Trials Centers(RCTCs) (N=9)

Table 3

The demographic characteristics of the subjects (N=77)

Table 4

The work-related characteristics of the subjects(1) (N=77)

Table 5

The work-related characteristics of the subjects(2) (N=77)

BE test: Bioequivalence test, PMS: Postmarketing Surveillance

Table 6

The difference between performance and importance of four roles

Table 7

The correlation between performance and importance of four roles

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