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What is a CRA / CRC ?
What is a CRA / CRC?
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 organisation to organisation. The job description will be the more or less same. A CRA is an individual employed by a pharmaceutical or device manufacturer, by a contract research organization (CRO) usually acting on a sponsor's behalf or by an academic institute conducting clinical trials.
Regulations require that sponsors of clinical studies. Select individuals who are qualified by training and experience to monitor their studies 21 CFR 31253 (d) ICH Guidelines 5182 (b) also states that Monitors be appropriately trained and their qualifications documented.
Cliniminds 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)
  • 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 distance learning training program teaches you all the responsibilities of the CRA.
What is a Study Coordinator or Clinical Research Coordinator?
This is the position who works for the Investigator / institution who handles most of the administrative responsibilities of a clinical trial, is the liaison between the clinical trial investigative site and the sponsor of the clinical trial, and reviews all data and records before a CRAs visit. The title can be research nurse, trial coordinator, study coordinator, research coordinator, or clinical coordinator.
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