Peng Hao1, Linda Wu2, Yanfei Liu3. 1. Clinical Department, WuXi MedKey Med-Tech Development (Shanghai) Co., Ltd, Shanghai, China. 2. Linda Wu Consulting, Independent Research Consultant, Loma Linda, CA, USA. 3. Clinical Trial Unit, Fudan University Shanghai Cancer Center, Shanghai,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.
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.
Authors: Clare E Hastings; Cheryl A Fisher; Margaret A McCabe; J Allison; D Brassil; M Offenhartz; S Browning; E DeCandia; R Medina; J Duer-Hefele; K McClary; N Mullen; M Ottosen; S Britt; T Sanchez; V Turbini Journal: Nurs Outlook Date: 2011-12-14 Impact factor: 3.250
Authors: Patricia Eckardt; Marilyn J Hammer; Margaret Barton-Burke; Margaret McCabe; Christine T Kovner; Liza Behrens; Heather Reens; Barry S Coller Journal: J Clin Transl Sci Date: 2017-11-16