J Korean Biol Nurs Sci.  2020 Aug;22(3):213-221. 10.7586/jkbns.2020.22.3.213.

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

• Park J
• Kim S

• KMID: 2505876
• DOI: http://doi.org/10.7586/jkbns.2020.22.3.213

Abstract

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.

Keyword

Nurse’s role; Clinical trial; Drug development