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Clinical Research Associate - Sponsor Dedicated
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Full-time
- Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Successful completion of a CRA Trainee Program or at least three months of on-site monitoring experience.
- 2 years of clinical research coordinator experience strongly preferred.
- i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
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