Job Description
**Job Overview**
Clinical Research Associate performs monitoring and site management work to ensure that sites are conducting the studies and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
**Essential Functions:**
• Perform site monitoring visits (selection, initiation, monitoring and close-out visits).
• Work with sites to adapt, drive and track subject recruitment plan in line with project needs.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approval...
Clinical Research Associate performs monitoring and site management work to ensure that sites are conducting the studies and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
**Essential Functions:**
• Perform site monitoring visits (selection, initiation, monitoring and close-out visits).
• Work with sites to adapt, drive and track subject recruitment plan in line with project needs.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approval...
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