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Clinical Research Associate:

Job description and activities

Job description

A clinical research associate (CRA) sets up, monitors and completes clinical trials.

A clinical trial is a scientific study of the effects, risks, efficacy and benefits of a medicinal product. These need to be carried out before a product reaches a hospital or the shelves of the local pharmacy. Trials are undertaken at various stages, or 'phases', and include: trials on healthy humans; trials on patients with a disease; and studies conducted after the launch of a new product to monitor safety and side effects during large-scale use.

Clinical trials are conducted by pharmaceutical companies or Contract Research Organizations (CROs) on their behalf.

 
   

Typical work activities include:

 
developing and writing trial protocols (outlining the purpose and methodology of a trial);  
 presenting trial protocols to a steering committee;  
designing data collection forms, known as case report forms (CRFs);  
Co-coordinating the ethics committee, who safeguard the rights, safety and well-being of all trial subjects;  
managing regulatory authority applications and approvals, who oversee the research and marketing of new and existing drugs;  
locating and assessing the suitability of facilities at a study center;  
briefing doctors/consultants (or investigators) on conducting the trial;  
setting up the study centers, which includes ensuring each center has the trial materials and checking that the investigator knows exactly what has to be done;  
monitoring the trial throughout its duration, which will involve visiting the study centers on a regular basis;  
 verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV);  
collecting completed CRFs from hospitals and general practices;  
writing visit reports;  
filing and collating trial documentation and reports;  
ensuring all unused trial supplies are accounted for;  
closing down study centers on completion of the trial;  
discussing results with a medical statistician, who usually writes technical trial reports;  
archiving study documentation and correspondence;  
 preparing final reports.  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Clinical Research Associate Training Program