A survey on work status and competencies of Clinical Research Nurses in China

Abstract

Background: The clinical trials industry in China has enjoyed robust growth; the demand for qualified personnel to conduct clinical trials with higher quality has increased. The Clinical Research Nurse has emerged as a new workforce in China.

Aims: This study aimed to examine the current work status of Clinical Research Nurses in China and to investigate their competencies in knowledge and behavior associated with this profession.

Methods: An online survey was analyzed. The current work status of Clinical Research Nurses in China was characterized. In addition, their competencies were self-assessed across nine competency categories and the "contribution to science" domain, based on the International Association of Clinical Research Nurses Scope and Standards of Practice.

Results: A total of 638 eligible questionnaires were included in the final analysis. Of whom, 98.28% (627/638) were females. The mean age was 35 years (range: 22-64 years). Over 80% of whom were working at the largest Chinese cities and the majority (78.2%) held a Bachelor's degree in nursing. The average time of clinical research experience was 5.67 years. Three quarters of the 638 had an annual income of <150,000 Yuan RMB. The average weekly working time was 45.46 h; clinical trial-related work accounted for 62.68% of their workload. There were some gaps between the Clinical Research Nurses' self-assessed competencies in knowledge and behavior, with the widest gaps along the ethical principles, leadership and professional development, protocol compliance, and document management categories.

Conclusion: This is the first large-scale survey of Clinical Research Nurses in China. Our results profile this emerging workforce as a population of young, moderately trained/experienced, predominantly female nurses working in the largest Chinese cities. They performed well on most knowledge/behavior parameters; still, gaps exist. Therefore, there is a pressing need to enhance professional education and training for Clinical Research Nurses in China.

Keywords: China; clinical research nurse workload; competency; job satisfaction; self-assessment; survey.

Figure 1.

Annual number of clinical trials registered in China from 2015 to 2020 (source: center for drug evaluation, national medical product administration, China; Chinadrugtrials. org.cn (2021) Total number of Registered China Drug Trials Up to Date. Available at: http://www.chinadrugtrials.org.cn/clinicaltrials.tongji.dhtml, accessed 28 Feb 2021). Each dot in the line graph and the associated number describe the number of clinical trials registered in China on any specific year (from 2015 to 2020).

Figure 2.

Radar plot illustrating self-assessed knowledge and behavior competencies by CRNs (N = 638) in China based on a survey conducted in 2019. The survey questionnaire was based on the Oncology Nursing Society (2016) Oncology Clinical Trials Nurse Competencies Model (blue dotted line/dots represent self-assessed knowledge competency scores and orange solid line/dots represent self-assessed behavior competency scores. Nine categories from the ONS model were assessed: ethical principles, protocol compliance, informed consent, subjects recruitment, subjects management, document management, data management and information technology, financial management, and leadership and professional development).