Clinical Research Associate (CRA)

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A Clinical Research Associate (CRA) is a knowledge worker who performs CRA tasks.



References

2023

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    • Q: How does a Clinical Research Associate (CRA) interact with a Clinical Study Site Monitor?
    • A: A Clinical Research Associate (CRA) and a Clinical Study Site Monitor (CSSM) are both involved in monitoring the progress of clinical studies, but they have different roles and responsibilities.

      The CRA is responsible for overall coordination and management of the study at the investigative sites. They are typically the primary point of contact for the study sponsor, and are responsible for ensuring that the study is conducted in accordance with the protocol and regulatory guidelines. They conduct site selection, initiation, monitoring, and close-out visits, and are responsible for ensuring that all study-related documents are accurate and complete.

      On the other hand, the Clinical Study Site Monitor (CSSM) is typically responsible for day-to-day monitoring of the study at the investigative sites. They are responsible for ensuring that the study is conducted in accordance with Good Clinical Practice (GCP) guidelines and that all regulatory requirements are met. They typically conduct on-site monitoring visits to assess the quality of the data being collected and to ensure that the study is being conducted in compliance with the protocol, SOPs and regulations.

      Both CRA and CSSM work closely together and communicate regularly to ensure the study is progressing well, and any issues are identified and addressed in a timely manner. The CRA will provide the CSSM with the necessary information and support to conduct the on-site monitoring visits, and the CSSM will report back to the CRA on any issues or concerns that are identified during their visits.

2021

  1. Prospects, Clinical research associate. Retrieved 28 April 2014.
  2. McMaster University, Certified Clinical Research Associate. Retrieved 28 April 2014.

2019