| Objects:With the increasing support for new drug research and development in China,the clinical research industry is flourishing,and the research quality requirements are constantly improving.Under such circumstances,the profession of clinical research coordinator,which appeared and expanded rapidly in China,has a good career prospect.The purpose of this study is to understand and study the professionalization of this profession in Shanghai as well as the existing problems,to provide suggestions and decision-making,and ultimately promote the professionalization of this profession.Methods:Two types of questionnaires were designed on the basis of literature research.Questionnaire 1 was designed for clinical researchers,including demographic information,attitudes towards clinical research,and professional evaluation of clinical research coordinators.The participants were researchers with clinical research experience in a third-class hospital in Shanghai.From July 20,2018 to July 30,2018,51 people were investigated by combining on-site and Wechat.Questionnaire 2 was designed for clinical research coordinators,including demographic information,skills self-assessment,training,job satisfaction(6 dimensions)and turnover intention(2 dimensions).The respondents were Shanghai Coordinator of Out-of-Hospital Clinical Research.From August 10,2018 to September 10,2018,420 questionnaires were sent out by micro-mail.416 questionnaires were recovered with a recovery rate of 99.05%.After checking,2 hospital CRC questionnaires were removed and 414 valid questionnaires were received,with an effective recovery rate of 98.57%.Results:(1)Professional evaluation of the out-of-hospital clinical research coordinator by the researchers in a third-class hospital in Shanghai(very satisfied to very unsatisfactory,1-5 points): overall satisfaction was relatively satisfactory(3.843±0.644),professional ethics(4.137±0.693)and work attitude(4.059±0.732)were higher,work ability(3.843±0.703),respectively.Professional skills(3.804±0.693)and professional knowledge(3.706±0.756)were in the middle,and job stability(2.745±0.744)was the lowest.(2)Self-evaluation of professional knowledge and professional skills of clinical research coordinators: the mastery of GCP in professional knowledge is the highest;the familiarity of EDC in professional skills is the highest.(3)Professional training: There are many forms of training,including induction training(100%)and on-the-spot operation teaching(94.2%),but little attention is paid to the knowledge of drug research and development(49.8%)and clinical research methodology(59.4%).The first three trainings needed by clinical research coordinators were SOP related to CRC operation(56%),communication skills(53.9%)and project management(53.1%).(4)Scope of responsibilities: The top five most needed by researchers are coordination of response to monitoring and inspection(4.43±0.67),research-related document management(4.43±0.67),assistance in handling reported adverse events(including SAE)(4.43 ± 0.64),ensuring the compliance of subjects(4.39±0.70),collection and management of research-related samples.(4.37±0.69).The five most important tasks in CRC's mind are to ensure the subject's compliance in visiting,research related document management,fill in case report forms and assist data answering,research related sample collection and management,and assist in reporting adverse events.Assist data answering,ensure the compliance of interviews,research related documents management,research related departments to communicate and coordinate,help recruit and screen subjects.(5)The self-rated job satisfaction of the clinical research coordinator was generally satisfactory,among which the satisfaction of colleague relationship was the highest(4.332±0.615),the satisfaction of organization was the second(4.263 ± 0.626),the satisfaction of job itself(4.18 ± 0.678)and the satisfaction of leadership behavior(4.167 ± 0.669)were the middle(P > 0.05).Subsequently,job reward satisfaction was the lowest(3.519 ± 0.811),but all the satisfaction was higher than the theoretical average.In addition,the organizational turnover intention(2.235±0.918)and the occupational turnover intention(2.279±0.945)of the CRC in Shanghai were lower than the theoretical average.Further analysis showed that there was no significant difference between organizational turnover intention and occupational turnover intention(P > 0.05).(6)In the demographic characteristics of 414 out-of-hospital clinical research coordinators in Shanghai,there were statistical differences in job satisfaction among different ages,marital status,working years and income(P < 0.05),and in job satisfaction with different educational background and income(P < 0.05).There were statistical differences in different income on the tendency of sexual turnover(P < 0.01);there were statistical differences in different working years and income on the tendency of occupational turnover(P < 0.05);(7)Regression analysis found that the factors of job satisfaction that had significant influence on the tendency of organizational turnover were organizational satisfaction in the CRC group outside Shanghai hospital.Satisfaction of work and return.In terms of job turnover,job satisfaction is the most important factor.Conclusion:1.From the perspective of professional specialization,the professional specialization level of out-of-hospital clinical research coordinators in Shanghai has developed rapidly.Although more attention has been paid to the training,they still lack the mastery of ethical knowledge and systematic training,and their professional knowledge and technical ability need to be improved.Researchers are satisfied with the professional ethics and attitude of the clinical research coordinator,but they are not satisfied with the job stability.Improving the job stability of the clinical research coordinator is beneficial to the professional level of the clinical research coordinator.In view of the current blank of regulations on clinical research coordinators in China,it is necessary for the government to promulgate similar laws and regulations on GCP to regulate the construction of the occupational system.It is necessary for clinical trial supervision departments and trade associations to improve the construction of the occupational standardization system.2.According to the level of job satisfaction,the job reward satisfaction of the out-of-hospital clinical research coordinator in Shanghai is lower than that of other dimensions.Organizational satisfaction and job reward satisfaction have significant influence on organizational turnover intention,job satisfaction has significant influence on occupational turnover intention.It is necessary for SMO companies to formulate salary,benefits and promotion system to cater for the high turnover tendency groups(such as those with less than three years' working experience)from the human resource level to cater for their expected returns,so that to reduce the occurrence of turnover. |
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