The CRA is responsible for the initiation, monitoring and closure of assigned sites in clinical studies, in compliance with sponsor's procedural documents, international guidelines such as ICH-GCP, and relevant local regulations. They ensure the sites deliver according to their respective commitment in the individual studies and act as a primary point of contact between site staff and the sponsor.
Job listings
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.
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.