1Doctoral student, College of Nursing, Yonsei University, Seoul, Korea.
2Professor, College of Nursing, Nursing Policy Research Institute, Yonsei University, Seoul, Korea.
Correspondence: Ko, Il-Sun. Department of Clinical Nursing Science, College of Nursing, Nursing Policy Research Institute, Yonsei University, Seoul, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, Korea. Tel: 82-2-2228-3255, Fax: 82-2-393-5440, isko16@yuhs.ac
• Received: November 15, 2011 • Revised: December 2, 2011 • Accepted: December 3, 2011
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.
1. Adams J. The role of research nurse. Nurs Times. 1994;90(36):70-72.
2. Bird J, Kirshbaum M. Towards a framework of advanced nursing practice for the clinical research nurse in cancer care. Clin Eff Nurs. 2005;9:161-171.
5. Han HS. Role accomplishment and job satisfaction of hospice nurse. 2008;Seoul, Ewha Womans University. Unpublished master's dissertation.
6. Hill G, MacArthur J. Professional issues associated with the role of the research nurse. Nurs Stand. 2006;20(39):41-47.
7. Hwang YS. Job analysis of clinical research nurse in oncology department. 2008;Seoul, Yonsei University. Unpublished master's dissertation.
8. Jeong 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.
9. Kang HS, Kim WO, Jeong IS, Baek JM. The working conditions and clinical trial practice of research nurses. Clin Nurs Res. 2004a;9(2):42-55.
10. Kang HS, Kim WO, Jeong IS, Choung SY, Shin SG. Developing the infrastructure for clinical trial in korea. J Korean Soc Clin Pharmacol Ther. 2004b;12(2):147-161.
11. Kang HS, et al. Developing the educational system for clinical trials(II). 2006;Kyung Hee University, Korea Food & Drug Administration.
12. Kim JS. Job satisfaction of the clinical research nurse. 2008;Taegu, Kyung-pook University. Unpublished master's dissertation.
13. Kim JW, Yeom YK, Lee SW, Lee SH, Lee YS. The study on the methods of activating clinical trial. Korea health industry development institute policy research paper. 2003.
14. Kim TE, Kim KH. Job status and job satisfaction among clinical research coordinator. J Korean Acad Nurs Adm. 2009;15(3):336-345.
15. Kirchhoff KT. The role of nurse researchers employed in clinical settings. Annu Rev Nurs Res. 1993;11:169-181.
17. Korea Food & Drug Administration, & National Institute of Toxicological Research. The basic training program for clinical trial professional(clinical research nurse). 2005.
19. Lee SY. Role cognition of head nurses and factors affecting the role performance of head nurses. 2004;Seoul, Yonsei University. Unpublished master's thesis.
20. Lynn MR. Determination and quantification of content validity. Nurs Res. 1986;35(6):382-385.
21. Rickard CM, Roberts BL, Foote J, McGrail MR. Job satisfaction and importance for intensive care unit research coordinators: results from binational survey. J Clin Nurs. 2007;16:1640-1650.
22. Rico-Villademoros F, Hernando T, Sanz JL, Lopez-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.
23. Seoul National University Hospital. Role of research team. 2001. Seoul national university hospital standard operating procedure.
24. Shin JY, Jo SJ, Yim HW, Jung HS, Lee WC, Park YJ, Park YM. Job satisfaction of clinical research coordinators in a university hospital. J Korean Soc Clin Pharmacol Ther. 2007;15(1):57-70.
25. Spilsbury K, Petherick E, Cullum N, Nelson A, Nixon J, Mason S. The role and potential contribution of clinical research nurses to clinical trials. J Clin Nurs. 2008;17:549-557.
27. Tomamichel M, Jaime H, Degrate A, De Jong J, Pagani O, Cavalli F, Sessa C. Proposing phase I studies : patients', relatives', nurses' and specialists' perceptions. Ann Oncol. 2000;11:289-294.
28. Yanagawa H, Akaishi A, Miyamoto T, Takai S, Nakanishi R, Irahara M. Role of clinical research coordinators in promoting clinical trials of drugs for surgical patients. Int Arch Med. 2008;1(26):1-4.
Table 1
Role Performance Related Factors of Participants (N=134)
*Missing responses excluded, Unit: Ten thousand won/month
CRC=Clinical Research Coordinator
Table 2
Role Performance Related Factors of Participants (N=134)
Table 3
Role Performance Item Scores (N=134)
Table 4
Differences in Role Performance Score of Participants by Role Performance Related Factors (N=134)
Table 5
Correlation of Role Performance Score and Role Performance Related Factors r(p), (N=134)
The role performance(1) is the sum of administration tasks(2) and participant management tasks(3) and coordination/advocacy tasks(4) and self-improvement(5).
CRC=Clinical Research Coordinator
Figure & Data
References
Citations
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Role Performance and Related Factors of the Clinical Research Coordinator
Role Performance and Related Factors of the Clinical Research Coordinator
Role Performance Related Factors of Participants (N=134)
*Missing responses excluded, Unit: Ten thousand won/month
CRC=Clinical Research Coordinator
Role Performance Related Factors of Participants (N=134)
Role Performance Item Scores (N=134)
Differences in Role Performance Score of Participants by Role Performance Related Factors (N=134)
Correlation of Role Performance Score and Role Performance Related Factors r(p), (N=134)
The role performance(1) is the sum of administration tasks(2) and participant management tasks(3) and coordination/advocacy tasks(4) and self-improvement(5).
CRC=Clinical Research Coordinator
Table 1
Role Performance Related Factors of Participants (N=134)
*Missing responses excluded, Unit: Ten thousand won/month
CRC=Clinical Research Coordinator
Table 2
Role Performance Related Factors of Participants (N=134)
Table 3
Role Performance Item Scores (N=134)
Table 4
Differences in Role Performance Score of Participants by Role Performance Related Factors (N=134)
Table 5
Correlation of Role Performance Score and Role Performance Related Factors r(p), (N=134)
The role performance(1) is the sum of administration tasks(2) and participant management tasks(3) and coordination/advocacy tasks(4) and self-improvement(5).
