Journal of Clinical Trials
Open Access

Abstract

Cross-sectional Study on Occupational Stress of Clinical Research Associates in China

Jun Ruan and Zhi-Feng Wang

Background: There had been large amount of discussion and comments regarding the clinical research associate (CRA) work stress and quality of life in DXY, the primary website focusing on medicine and pharmaceutics in China. Quite a number of clinical research professionals described various examples and cases reflecting higher occupational stress of the Chinese CRAs. No relevant paper to date in the world have been formally published that assessing the CRA’s workload or occupational stress. The purpose of the study was to investigate the occupational stress of the CRAs in China.
Methods: Chinese CRAs with more than 6 months monitoring experiences were enrolled into the study by convenient sampling. The number of participants from multinational CROs, local CROs, multinational pharmaceuticals and local pharmaceuticals were controlled to a ratio of approximately 4:3:2:1. A total of 200 CRAs were surveyed for work stressor, personal strain and coping resources by Occupational Stress Inventory Revised (OSI-R) Chinese edition during January to March 2013.
Results: Among the 178 participants evaluable, about 71.3% were females. Their average age was 28.76 years (SD=3.97 years), ranging from 21 to 42 years. 87.1% of the participants had a Bachelor’s degree or above. Around 29.8% of the participants had medicine background, and 48.3% had pharmacy background. Role Ambiguity (RA) stressor was higher among the CRAs of age ≤ 25 years, while responsibility was higher among the CRAs of age ≥ 36 years age group. Vocational Strain (VS) was also higher among those of age ≤ 25 years. A trend of higher self-care resources was observed in elder CRAs and those of higher education levels. The CRAs from multinational CROs had highest coping resources.
Conclusion: This study revealed that the CRAs in China had moderate work stressor, personal strain and coping resources. The occupational stresses were varying amongst Chinese CRAs of different gender, ages, education levels and company types. The CRAs at age of ≤ 25 years had higher occupational stress than other age groups. The CRA’s personal strain and its facets had their predicating factors, role insufficiency and role boundary were the main risk factors, while rational coping, recreation, social support and self-care were the protecting factors.