Abstract
Objective
To understand the occupational situation of clinical research associates (CRAs) in terms of workloads, difficulties in monitoring and occupational satisfaction. To provide reference for further improving the occupational status of CRA, enhance the quality of clinical trials, and monitoring efficiency.
Methods
This study is a national cross-sectional survey, and over a 2-month period. The research data are collected through self-made questionnaires, consisting of such five sections on CRAs as basic information, work situation, satisfaction with other participants in clinical trials, career satisfaction, suggestions. The questionnaire was put into a QR code for invited CRAs to scan and participate anonymously. All the data were directly exported for statistical analysis after collected.
Results
The survey ultimately included 401 valid questionnaires, of which 71.32% were female, the average age is 27.86 years old, 95.01% had a bachelor's degree or above, and 60% had a pharmaceutical major. 80% of CRA work hours exceed the standard working hours requirement. The frequency of CRA business trips has decreased under the impact of the Covid-19 epidemic, with 79.3% of CRAs traveling for less than 7 days per month. Only 49.63% of people were satisfied with the current salary level, but about 80% of people are satisfied with promotion channels and company training. It was suggested by more than 80% of CRAs that the application materials for clinical trials should be unified nationwide and an ethical mutual recognition system, which allows the approved ethical results of one ethics committee to be recognized across all research sites involved, be implemented.
Conclusions
Currently, CRAs has a relatively large workload and generally works overtime. The monitoring difficulties faced by CRAs from three aspects: hospitals, companies, and themselves. With the number of CRAs on the rise, it is necessary to generate more professional associates with higher quality and increase corresponding training channels. Meanwhile, efforts remain to be made by hospitals to reinforce their management and provide better training for investigators so as to improve the efficiency of monitoring. It is incumbent on the enterprises to provide matching salaries and benefits with a view to improving the retention of employees.