Manage the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues. Participate in the evaluation and implementation of patient-focused strategies for assigned trials, as applicable.
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The Clinical Research Associate I (CRA I) primarily oversees the progress of clinical investigations by conducting site interim monitoring visits to clinical sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by RQM+ and sponsors. Works closely with the Clinical Trial Manager (CTM) and/or Lead CRA to ensure all monitoring activities are conducted according to study requirements.
To prepare for and manage clinical studies for our diagnostic assays, you will support external studies, including site selection, site initiation visits and routine monitoring, and serve as the liaison between clinical sites and Pattern teams. You’ll have the opportunity to collaborate across the organization including with Assay Development, Hardware, Software, Quality, and Regulatory.