Construction of clinical research coordinator position competence model under new circumstances
Objective:To develop a competency model for clinical research coordinators,which can be used as a reference for their cultivation and testing.Methods:By searching literature and conducting theoretical research,the evaluation indicators system was initially established for the competency of clinical research coordinators.Through the Delphi method,37 experts were consulted in two rounds of questionnaires to determine the final competency evaluation indicator system,and the analytic hierarchy process was used to assign weights to the indicators.Results:The recovery rate of both rounds of expert consultation was 100％,and the calculated authority coefficient of the experts was 0.8703.Five main competencies and forty sub-competencies were ultimately identified.The main competencies were clinical trial operation skills and abilities,personality traits,professional knowledge of clinical trials,understanding and recognition of job responsibilities,and values.The respective weight coefficients were 0.4035,0.2271,0.1827,0.1158,0.0710,respectively.The key competencies,defined as those with combination weights greater than 0.04,included source file and data standardization management,legal and regulatory knowledge,relevant documentation for test projects,confidentiality awareness,standard operating procedures (SOP) for clinical trials,and adaptability.The respective weight coefficients were 0.0606,0.0591,0.0544,0.0539,0.0479,and 0.0469,respectively.Conclusion:The preliminarily constructed competency model for clinical research coordinators has high reliability,providing scientific base for the selection,training,and evaluation of clinical research coordinators.
clinical research coordinatordrug clinical trialjob competencyDelphi method
万方数据
维普
