Journal of Korean Biological Nursing Science

  • 제22권3호
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  • Pages.213-221
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  • 2020
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  • 2383-6415(pISSN)
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  • 2383-6423(eISSN)
한국기초간호학회 (Korean society of Biological Nursing Science)
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신약개발을 위한 임상연구간호사의 역할수행과 관련 요인

Role Performance and Related Factors of Clinical Research Nurses in New Drug Development

  • Park, Jeaeun (Department of Nursing, Changwon National University) ;
  • Kim, Shinmi (Department of Nursing, Changwon National University)
  • 투고 : 2020.08.03
  • 심사 : 2020.08.20
  • 발행 : 2020.08.31
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초록

Purpose: The purpose of this study was to explore the role performance and related factors of clinical research nurses (CRN) in the process of clinical trials of new drug development. Methods: Study participants were CRN whose affiliation was in non-capital areas and who had been working longer than three months at the time of the data collection. The data collection was conducted with a semi-structured questionnaire development by Hwang & Go, 2011 comprising 16 items of participants' characteristics and 60 items of role performance via in-person and online. Additionally, opinions which would be necessary to establish the CRN role were questioned for the future. A total of 141 questionnaires of 151 questionnaires responses were analyzed using descriptive statistics, t-test, and ANOVA for data analysis as appropriate. Results: The level of overall role performance was above average (5.61±0.90) with the highest in subject care (6.04 ± 0.96) and management and the lowest in self-development (4.39 ± 1.52). The only factor affecting overall role performance was employment status and the only sub-category affected by factors of employment status, and some general characteristics was self-development. Conclusion: From study results, it can be concluded that the CRN seem to perform their proper role. Nonetheless, self-development should be considered as critical aspect for better CRN competency, which is an important aspect toward improving the CRN role performance. Additionally, efforts to improve the level of role performance must be established through stable employment and concrete departmental placement as suggested in this study.

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참고문헌

  1. Korean Clinical Trials Information Center. Domestic clinical trial status in 2019 [Internet]. Seoul: Korean Clinical Trials Information Center; 2019 [cited June 10, 2020]. Available from: https://www.koreaclinicaltrials.org/kr/contents/datainfo_data_01_tab02/view.do
  2. Ministry of Food and Drug Safety. The results of the 2018 clinical trial approval are announced [Internet]. Cheongju: Ministry of Food and Drug Safety; 2019 [cited June 10, 2020]. Available from: https://www.mfds.go.kr/brd/m_99/view.do?seq=43284
  3. Ministry of Law. Legal justice dictionary [Internet]. Sejong: Ministry of Law; 2020 [cited June 10, 2020]. Available from: http://www.law.go.kr/LSW/lsTrmScListP.do?q=%EC%9E%84%EC%83%81%EC%8B%9C%ED%97%98&outmax=15&fsort=10
  4. 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. International Archives of Medicine. 2008;1(1):26. https://doi.org/10.1186/1755-7682-1-26.
  5. Jung IS, Hwang YS, Jung JH, Yoon JY, Lee EJ, Seo SH. 2017 domestic CRC manpower survey and job change analysis. Result Report. Pusan: Pusan National University Industry-University Cooperation Foundation; 2017. Dec.
  6. Kim HY. Experience of patients with cancer participating in a clinical trial for the development of a new drug. Asian Oncology Nursing. 2006;6(2):121-132.
  7. Gibbs CL, Lowton K. The role of the clinical research nurse. Nursing Standard. 2012;26(27):37-40. https://doi.org/10.7748/ns2012.03.26.27.37.c8986
  8. Kunhunny S, Salmon D. The evolving professional identity of the clinical research nurse: a qualitative exploration. Journal of Clinical Nursing. 2017;26(23-24):5121-5132. https://doi.org/10.1111/jocn.14055.
  9. Mueller MR. Mamo L. The nurse clinical trial coordinator: benefits and drawbacks of the role. Research and Theory for Nursing Practice. 2002;16(1):33-42. https://doi.org/10.1891/rtnp.16.1.33.52992
  10. Jones CT, Hastings C. Wilson LL. Research nurse manager perceptions about research activities performed by non-nurse clinical research coordinators. Nursing Outlook. 2015;63(4):474-483. https://doi.org/10.1016/j.outlook.2015.02.002.
  11. Do SJ. The role of clinical research nurses at regional clinical trials centers. Journal of Korean Academy of Nursing Administration. 2010;16(3):348-359. http://doi.org/10.11111/jkana.2010.16.3.348.
  12. Choi SY. Job and workload, importance and job satisfaction of the anticancer drug research coordinator [master's thesis]. Seoul: Ewha Women University; 2014. p. 12-22
  13. Hwang YS, Go IS. Role performance and related factors of the clinical research coordinator. Journal of Korean Academy of Nursing Administration. 2011;17(4):524-537. https://doi.org/10.11111/jkana.2011.17.4.524
  14. Korea Clinical Trial Industry Foundation. Announcement of 2015 clinical trial professional certification [Internet]. Seoul: Korea Clinical Trial Industry Foundation; 2015 [cited JUNE 10, 2020]. Available from: http://lms.konect.or.kr/web/center/noticeView.do?boardIdx=133&certifiedYn=Y&pageIndex=4&searchKeyword=&searchCondition=all
  15. Kang HS, Jeong IS, Kim WO, Baek JM. Working conditions of domestic research nurses and characteristics of clinical trial work. Journal of Korean Clinical Nursing Research . 2004;9(2):42-55.
  16. Browning S.M. The clinical research coodinator: perception of roles, responsibilities, and competence [dissertation]. Washington D.C.: Georgetown University; 2019. p. 1-2
  17. American Nurses Association and International Association of Clinical Research Nurses. Clinical research nursing: scope and standards of practice. Silver Sprina, MD: American Nurse Association; 2016. p. 1-2
  18. Green L. Explaining the role of the nurse in clinical trials. Nursing Standard (through 2013), 2011;25(22):35-39. https://doi.org/10.7748/ns.25.22.35.s50
  19. Micklos L. The nephrology clinical research nurse role: potential role conflicts. Nephrology Nursing Journal. 2016;43(3):257-261.
  20. U.S. Department of Health and Human Services Food and Drug Administration, FDA. Guidance for industry, investigator responsibilities protection of the rights, safety and welfare of study subjects [Internet]. Washington, D.C.: U.S. Department of Health and Human Services Food and Drug Administration, FDA; 2009 [cited June 10, 2020]. Availablefrom:http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm187772.pdf.
  21. Mori C, Mullen N, Hill EE. Describing the role of the clinical research nurse. Research Practitioner. 2007;8(6):220-228.
  22. Ko SK, Jeon CY, Park JH, Han CH, Go HY, Yoon YS, Joo GH, et al. Development of CRF and SOPs for the Identification of risk factors of the cerebrovascular diseases in the east and west medicine. Journal of Korean Medicine. 2006;27(1):204-219.
  23. Ministry of Food and Drug Safety. Status of designation as a training institution for clinical trial workers [Internet]. 2019[cited 2020 June 10]. Available from: https://www.mfds.go.kr/search/search.do
  24. Sverke M, Hellgren J. The nature of job insecurity: understanding employment uncertainty on the brink of a new millennium. Applied Psychology. 2002;51(1):23-42. https://doi.org/10.1111/1464-0597.0077z
  25. Kim KJ. Human resource management system for nurses: challenges and research directions. The Korean Journal of Health Service Management. 2012;6(1):247-258. https://doi.org/10.12811/kshsm.2012.6.1.247
  26. Platonov P, Varshavsky S. Why do patients participate in trials? Good Clinical Practice Journal. 2002;9(11):11.
  27. Kim SK, Lim JY. Effects of work environment, job satisfaction, and organizational commitment on turnover intention of clinical research coordinator nurses. The Journal of the Korea Contents Association. 2018;18(5):175-190. https://doi.org./10.5392/JKCA.2018.18.05.175
  28. Hong SK. A study on the effect of clinical labor coordinator's emotional labor on turnover intention [master's thesis]. Pocheon: Cha Medical University; 2019. p 15