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NEW COURSE - Statistics for Clinical Research
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What is a CRA?
What is a CRC?
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What is a CRA?

 

A Clinical Research Associate (CRA) can also be called a Monitor, a Clinical Monitor, a Trial Monitor or a Medical Monitor. The title will vary from company to company. The job description will be the same. A CRA is an individual employed by a pharmaceutical or medical device manufacturer, by a contract research organization (CRO) usually acting on a sponsor's behalf or by an academic institute conducting clinical trials.  

 

Federal Regulations require that sponsors of clinical studies select individuals who are qualified by training and experience to monitor their studies 21 CFR 312.53 (d). ICH Guidelines 5.18.2 (b) also states that Monitors be appropriately trained and their qualifications documented.

 

Our online program provides this required training.

 

The major responsibilities of a CRA are:

  • Assure the protection of the rights, safety and well being of human study subjects.
  • To analyze and evaluate clinical data, to ensure investigator and site compliance with the study drug protocol, overall clinical objectives, FDA regulations, ICH Guidelines, Good Clinical Practice (GCP) and HIPAA. 
  • Identify, help in the study site selection process, initiate, and eventually close out clinical study sites.
  • To monitor the progress of clinical study sites participating in a clinical study, and to assure the protocol is followed and data is reported accurately.
  • To make certain that the scientific integrity of the data collected is protected and verified.
  • Assure that adverse events are correctly documented and reported.
  • Review all case report forms and compare them to source documents.

This online training program teaches you all the responsibilities of the CRA.