Clinical Research Associate

A representative provided by the study Sponsor to review and monitor subject study files to ensure subject safety, regulatory documents are up to date, perform drug/device accountability, source data review, source data verification, ensure site has enough study supplies and keep track of any staff changes at the site and ensure the site is following the protocol, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidelines and Code of Federal Regulations. CRAs perform 4 types of visits: Site Qualification Visits (to determine if the principal investigator and site is a good fit for the study), Site Initiation Visits (once the PI is selected for study by the sponsor, the CRA will train the PI and site on the study they are selected for) Interim Monitoring Visits (to monitor the study progress at the research site and to ensure subject safety once they have been enrolled in the study among other on site tasks and responsibilities) and Close Out Visits (to end the study at the site)

Interested in learning more? Check out our Monitoring 101 course HERE!