JobMesh

Clinical Research Associate Western US

Glaukos Corporation · US

How will you make an impact? Responsible for assessing the study capabilities of potential study sites, training, on-site monitoring, closure, and management...

Job description

How will you make an impact? Responsible for assessing the study capabilities of potential study sites, training, on-site monitoring, closure, and management of sites participating in clinical research studies sponsored by Glaukos. The SR. Clinical Research Associate (CRA) is responsible for maintaining data integrity and monitoring study conduct in accordance with regulations and the study protocol at the site level. What will you do?: CLINICAL SITE MONITORING: - Travel to investigative sites to conduct site qualification, initiation, interim monitoring, and close-out visits - Assist with selection of potential investigators - Conduct initial and ongoing site training throughout the course of the study Verify informed consent process is properly followed - Evaluate investigator compliance with the study protocol and applicable regulations - Verify sites are collecting all required source data per protocol, accurately completing Case Report Forms, and resolving all data queries - Review the regulatory binder and essential documents at the site and verify all documents are appropriately filed - Verify and reconcile site’s essential documents against the trial master file as required...