A survey for the core work activity of clinical research coordinator in China

Abstract

Objective Sorting out work activity of China Clinical Research Coordinator(CRC), defining the core work activity of China CRC, and making comparison with foreign CRC’s. Providing basic data to establish training system and occupational skill assessment system for China CRC. Methods This is a cross-section design survey. The method for sampling will be the convenient sampling combine the snowball sampling. A self-administered questionnaire was introduced. Data managed by Excel and analyzed by SPSS. The frequency, percentage, mean and SD will used for the description of the CRC’s demographics information and vocation characteristics. The core work activities of CRCs were defined with the method which used to define core work activities of CRCs in foreign literatures. Results Totally 227 questionnaires were returned, 223 effective questionnaires were used for analysis, the effective rate is 98%. Around 89% of CRCs are female. The mean age is 27.5±3.8 years. Around 72% of CRCs owned bachelor degree, 24% are junior college degree, 4% are master degree. Around 43% CRCs are nurse background, 34% are pharmacy background, 16% are medical background. Around 55% of CRCs owned 3 000-5 000RMB income. More than 50% of the CRCs had worked in this position for less than 1.5 years. Totally 10 items of work activities are defined as the core work activity of China CRCs, mainly focus on clinical trial data collection and management. Comparing to foreign CRC, the involvement of China CRC on CRF completion, query solution, study document management, assisting Clinical Research Associate (CRA) on monitoring, AE and SAE reporting are lower than foreign CRC, and the involvement on assisting investigator on patient screening, lab-test report collection and management, sample delivery and management, assisting investigator on patient visit arrangement are higher than foreign CRC. Conclusions The CRC in China has now involved in all work activities of the whole process of clinical trials, their core work activities mainly in the phase of clinical trial conduct, they play an important role in clinical trial operation. Due to the immature training system and the unclear job description, there are differences Between Foreign CRC and China CRC on working activity. Key words: Clinical research coordinator; Clinical trial coordinator; Site coordinator; Core work activity; Cross-sectional survey