• KANAD
  • Contact us
  • E-Submission

J Korean Acad Nurs Adm : Journal of Korean Academy of Nursing Administration

OPEN ACCESS
mobile search button mobile menu button
Search
Advanced Search
ABOUT
BROWSE ARTICLES
EDITORIAL POLICY
FOR CONTRIBUTORS

Articles

Page Path

Original Article

The Role of Clinical Research Nurses at Regional Clinical Trials Centers

Seon Ju Do1
Journal of Korean Academy of Nursing Administration 2010;16(3):348-359.
Published online: September 30, 2010

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: September 15, 2010   • Revised: September 27, 2010   • Accepted: September 28, 2010

Copyright © 2010 Korean Academy of Nursing Administration

  • 13 Views
  • 0 Download
  • 9 Crossref
prev

Full Article

Download PDF Download PDF
  • 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.
  • Key Words: Clinical Research Nurse; Clinical Trial; Role
  • 1. Carpentier WS. Clinical research nurse career ladder. Res Nurse. 1998;4(5):1-13.
  • 2. Hong JH. South Korea and Japan comparative study of awareness of the clinical trial, researchers. 2009;Seoul, Seoul National University. Unpublished master's thesis.
  • 3. Hwang YS. Job analysis of clinical research nurse in oncology department. 2008;Seoul, Yonsei University. Unpublished master's thesis.
  • 4. Jang IJ. Modanization of Clinical Trial Infrastructure. J Korean Soc Clin Pharmacol Ther. 2006;14(1):29-32.
  • 5. Jung IS, Kang HS, Kim WO. Current status of educational experience and preferred educational and certification program of clinical research nurses: A questionnaire survey. J Korean Soc Clin Pharmacol Ther. 2005;13(2):195-207.
  • 6. Kang HS. Developing the educational system for clinical trials (II). 2006;Korea Food & Drug Administration.
  • 7. Kang HS, Jeong IS, Choung SY, Shin SG, Kim WO. Developing the infrastructure for clinical trial in Korea. J Korean Soc Clin Pharmacol Ther. 2004b;12(2):147-162.
  • 8. Kang HS, Kim WO, Jeong IS, Baik JM. The working conditions and clinical trial practice of research nurses. J Korean Clin Nurs Res. 2004a;9(2):42-55.
  • 9. Kim JS. Job satisfaction of the clinical research nurse. 2008;Taegu, Kyung-pook University. Unpublished master's thesis.
  • 10. Korea Food & Drug Administration & National Institute of Toxicological Research. Training for clinical trial involved (CRC). 2005.
  • 11. Korea Food & Drug Administration. Korea Good Clinical Practice. 2008.
  • 12. Korea Food & Drug Administration. Bioequivalence Guideline. 2008.
  • 13. Korea National Enterprise for Clinical Trials. http://www.konect.or.kr/
  • 14. Lee TH. The government's clinical trials industrialization strategy. 1986;01 03 Digital Bosa. http://www.digitalbosa.co.kr/
  • 15. Lynn MR. Determination and quantification of content validity. Nurs Res. 1986;35(6):382-385.
  • 16. Park MS. The role of RCTC to activate early-phase clinical trials. J Korean Soc Clin Pharmacol Ther - Spring symposium. 2006;2006, May; 19-24.
  • 17. Rico-Villademoros F, Hernando T, Sanz J, Antonio López-Alonso A, Salamanca O, Camps C, Rosell R. The role of the clinical research coordinator -data manager- in oncology clinical trials. BMC Med Res Methodol. 2004;4:6. [On-line] http://www.pubmedcentral.nih.gov/
  • 18. Seoul National University Hospital, Clinical Trials Center. Standard operation procedures. 2008;Seoul, Seoul National University Hospital.
  • 19. Shin JY, Jo SJ, Yim HW, Jung HS, Lee WC, Park YJ, Park YM. Job Satisfaction of Clinical Eesearch Coordinators in a University Hospital. J Korean Soc Clin Pharmacol Ther. 2007;15(1):57-70.
  • 20. Shin SG, Jang IJ. New drug application process. J Korean Soc Clin Pharmacol Ther. 2001;9(2):126-137.
  • 21. Song SM. The recognition of KGCP among CRC in an University Hospital located in Seoul. 2008;Seoul, Catholic University. Unpublished master's thesis.
Table 1
The general characteristics of the experts (N=9)
jkana-16-348-i001.jpg
Table 2
The characteristics of the Regional Clinical Trials Centers(RCTCs) (N=9)
jkana-16-348-i002.jpg
Table 3
The demographic characteristics of the subjects (N=77)
jkana-16-348-i003.jpg
Table 4
The work-related characteristics of the subjects(1) (N=77)
jkana-16-348-i004.jpg
Table 5
The work-related characteristics of the subjects(2) (N=77)
jkana-16-348-i005.jpg

BE test: Bioequivalence test, PMS: Postmarketing Surveillance

Table 6
The difference between performance and importance of four roles
jkana-16-348-i006.jpg
Table 7
The correlation between performance and importance of four roles
jkana-16-348-i007.jpg

Figure & Data

References

    Citations

    Citations to this article as recorded by  
    • The role of clinical trial nurses: Transitioning from clinicians to clinical research coordinators
      Hye‐Ja Park, Soyoung Yu
      International Journal of Nursing Practice.2022;[Epub]     CrossRef
    • Development of Performance Indicators for Clinical Research Coordinators Using the Balanced Scorecard in South Korea
      Youn Sun Hwang, Tae Wha Lee
      Therapeutic Innovation & Regulatory Science.2019; : 216847901987075.     CrossRef
    • Experience of Hospital Administrative Nurses' Work Adjustment
      Hyun-Ju Lee, Jae-Hyun Ha, Yun-Seo Jung, Jungmi Yun
      Journal of Korean Academy of Nursing Administration.2019; 25(5): 424.     CrossRef
    • Validation of a Questionnaire to Delineate the Clinical Trial Nursing Roles in Korea
      In Jung Choi, Hye-Ja Park
      Cancer Nursing.2018; 41(3): E30.     CrossRef
    • The Communication Styles and Nursing Service Satisfaction of Clinical Research Nurses Perceived by Clinical Subjects
      Mi Seon Seo, Young Im Park
      The Journal of Korean Academic Society of Nursing Education.2016; 22(4): 559.     CrossRef
    • Work Experience of Irregular Clinical Research Nurses
      Hae-Ok Kim
      Journal of Digital Contents Society.2015; 16(4): 623.     CrossRef
    • Job Analysis of Coordinator Working in the Regional Cardiocerebrovascular Center
      Kyung-Sook Cho, Sung-Bok Kwon, Kun Sei Lee, Haeng-Mi Son
      Journal of muscle and joint health.2014; 21(2): 153.     CrossRef
    • Comparison of the Perceptions between Investigators and Clinical Research Associates in Role Performances of Clinical Research Coordinators
      Il-Sun Ko, Youn-Sun Hwang, Ho-Kon Kim
      Journal of the Korea Academia-Industrial cooperation Society.2014; 15(8): 5095.     CrossRef
    • Role Performance and Related Factors of the Clinical Research Coordinator
      Youn Sun Hwang, Il-Sun Ko
      Journal of Korean Academy of Nursing Administration.2011; 17(4): 524.     CrossRef

    Download Citation

    Download a citation file in RIS format that can be imported by all major citation management software, including EndNote, ProCite, RefWorks, and Reference Manager.

    Format:

    Include:

    The Role of Clinical Research Nurses at Regional Clinical Trials Centers
    J Korean Acad Nurs Adm. 2010;16(3):348-359.   Published online September 30, 2010
    DOI: https://doi.org/10.11111/jkana.2010.16.3.348
    Download Citation
    Download a citation file in RIS format that can be imported by all major citation management software, including EndNote, ProCite, RefWorks, and Reference Manager.
    Format:
    • RIS — For EndNote, ProCite, RefWorks, and most other reference management software
    • BibTeX — For JabRef, BibDesk, and other BibTeX-specific software
    Include:
    • Citation for the content below
    The Role of Clinical Research Nurses at Regional Clinical Trials Centers
    J Korean Acad Nurs Adm. 2010;16(3):348-359.   Published online September 30, 2010
    DOI: https://doi.org/10.11111/jkana.2010.16.3.348
    Close

    Related articles

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

    The general characteristics of the experts (N=9)

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

    The demographic characteristics of the subjects (N=77)

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

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

    BE test: Bioequivalence test, PMS: Postmarketing Surveillance

    The difference between performance and importance of four roles

    The correlation between performance and importance of four roles
    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

    Table 1

    Table 2

    Table 3

    Table 4

    Table 5

    Table 6

    Table 7

    J Korean Acad Nurs Adm : Journal of Korean Academy of Nursing Administration

    ABOUT

    BROWSE ARTICLES 

    EDITORIAL POLICY

    FOR CONTRIBUTORS  

    © Korean Academy of Nursing Administration.
    TOP