Role Performance and Related Factors of the Clinical Research Coordinator

임상연구코디네이터의 역할수행과 관련 요인

  • Hwang, Youn-Sun (College of Nursing, Yonsei University) ;
  • Ko, Il-Sun (College of Nursing, Nursing Policy Research Institute, Yonsei University)
  • Received : 2011.11.15
  • Accepted : 2011.12.03
  • Published : 2011.12.30

Abstract

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 $5.74{\pm}0.67$ of a possible 7) and the degree of role performance in the management task sub dimension (mean average $6.12{\pm}0.77$ 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.

Keywords

References

  1. Adams, J. (1994). The role of research nurse. Nursing Times, 90(36), 70-72.
  2. Bird J., & Kirshbaum M. (2005). Towards a framework of advanced nursing practice for the clinical research nurse in cancer care. Clinical Effectiveness in Nursing, 9, 161-171 https://doi.org/10.1016/j.cein.2006.08.008
  3. Bowen, K. E., & Rice, L. S. (1998). Who is clinical research nurse? Research Nurse, 4(4), 1-4.
  4. Do, S. J. (2010). The role of clinical research nurses at regional clinical trials centers. Journal of Korean Academy of Nursing Administration, 16(3), 348-359. https://doi.org/10.11111/jkana.2010.16.3.348
  5. Han, H. S. (2008). Role accomplishment and job satisfaction of hospice nurse. Unpublished master's dissertation, Ewha Womans University, Seoul.
  6. Hill G., & MacArthur J. (2006). Professional issues associated with the role of the research nurse. Nursing Standard, 20(39), 41-47
  7. Hwang, Y. S. (2008). Job analysis of clinical research nurse in oncology department. Unpublished master's dissertation, Yonsei University, Seoul.
  8. Jeong, I. S., Kang, H. S., & Kim, W. O. (2005). Current status of educational experience and preferred educational and certification program of clinical research nurses: a questionnaire survey. The Journal of Korean Society for Clinical Pharmacology and Therapeutics, 13(2), 195-207.
  9. Kang, H. S., Kim, W. O., Jeong, I. S., & Baek, J. M. (2004a). The working conditions and clinical trial practice of research nurses. Clinical Nursing Research, 9(2), 42-55.
  10. Kang, H. S., Kim, W. O., Jeong, I. S., Choung, S. Y., & Shin, S. G. (2004b). Developing the infrastructure for clinical trial in korea. The Journal of Korean Society for Clinical Pharmacology and Therapeutics, 12(2), 147-161.
  11. Kang, H. S. et al. (2006). Developing the educational system for clinical trials(II). Kyung Hee University, Korea Food & Drug Administration.
  12. Kim, J. S. (2008). Job satisfaction of the clinical research nurse. Unpublished master's dissertation, Kyung-pook University, Taegu.
  13. Kim, J. W., Yeom, Y. K., Lee, S. W., Lee, S. H., & Lee, Y. S. (2003). The study on the methods of activating clinical trial. Korea health industry development institute policy research paper.
  14. Kim, T. E., & Kim, K. H. (2009). Job status and job satisfaction among clinical research coordinator. Journal of Korean Academy of Nursing Administration, 15(3), 336-345.
  15. Kirchhoff, K. T. (1993). The role of nurse researchers employed in clinical settings. Annual Review of Nursing Research, 11, 169-181.
  16. Korea Food & Drug Administration. (2010). Clinical trials approved by KFDA. Retrieved October 10, 2011, from Korea National Enterprise for Clinical Trials Web site: http://www.konect.or.kr/html/02_clinic/clinic_03.jsp?header=02&sub=04
  17. Korea Food & Drug Administration, & National Institute of Toxicological Research. (2005). The basic training program for clinical trial professional(clinical research nurse).
  18. Korea National Enterprise for Clinical Trials. (2011). Clinical trial? Retrieved October 10, 2011, from Web site: http://www.konect.or.kr/html/02_clinic/clinic_01.jsp
  19. Lee, S. Y. (2004). Role cognition of head nurses and factors affecting the role performance of head nurses. Unpublished master's thesis, Yonsei University, Seoul.
  20. Lynn, M. R. (1986). Determination and quantification of content validity. Nursing Research, 35(6), 382-385.
  21. Rickard, C. M., Roberts, B. L., Foote, J., & McGrail, M. R. (2007). Job satisfaction and importance for intensive care unit research coordinators: results from binational survey. Journal of Clinical Nursing, 16, 1640-1650. https://doi.org/10.1111/j.1365-2702.2007.01713.x
  22. Rico-Villademoros, F., Hernando, T., Sanz, J. L., Lopez-Alonso, A., Salamanca, O., Camps, C. & Rosell, R. (2004). The role of the clinical research coordinator-data manager- in oncology clinical trials. BioMedCentral Medical Research Methodology, 4:6. https://doi.org/10.1186/1471-2288-4-6
  23. Seoul National University Hospital. (2001). Role of research team. Seoul national university hospital standard operating procedure.
  24. Shin, J. Y., Shin, Jo, S. J., Yim, H. W., Jung, H. S., Lee, W. C., Park, Y. J., & Park, Y. M. (2007). Job satisfaction of clinical research coordinators in a university hospital. The Journal of Korean Society for Clinical Pharmacology and Therapeutics, 15(1), 57-70.
  25. Spilsbury, K., Petherick, E., Cullum, N., Nelson, A., Nixon, J., & Mason, S. (2008). The role and potential contribution of clinical research nurses to clinical trials. Journal of Clinical Nursing, 17, 549-557.
  26. Stephens-Lloyd, A. (2004). The extended role of the clinical research nurse: building an evidence base for practice. Nursing Times Research, 9, 18-27. https://doi.org/10.1177/136140960400900104
  27. Tomamichel, M., Jaime, H., Degrate, A., De Jong, J., Pagani, O., Cavalli, F., & Sessa, C. (2000). Proposing phase I studies : patients', relatives', nurses' and specialists' perceptions. Annals of Oncology, 11, 289-294 https://doi.org/10.1023/A:1008393031299
  28. Yanagawa H., Akaishi A., Miyamoto T., Takai S., Nakanishi R., & Irahara M. (2008). Role of clinical research coordinators in promoting clinical trials of drugs for surgical patients. International Archives of Medicine, 1(26), 1-4.