Clinical Research Associate

<p class=""p1"">Here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve the eyesight of people worldwide. Because we&rsquo;re a rapidly growing company with a dynamic, fast-paced culture, employees here are empowered with more diverse and enriching challenges than might not be possible at a larger company.</p>

Los Angeles, CA

Glaukos

<h4>Founded in 1998, Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.</h4> <h4>Our company was the first company to bring to market Micro-Invasive Glaucoma Surgery (MIGS), the micro-invasive procedure which revolutionized the treatment and management of glaucoma. In 2012, we launched our first MIGS device&mdash;the iStent&reg;&mdash;in the United States, followed by our next-generation iStent&nbsp;inject&reg;&nbsp;device in September 2018 and iStent&nbsp;inject&reg;&nbsp;W in September 2020.</h4> <h4>In November 2019, Glaukos acquired Avedro, maker of the first and only FDA-approved cross-linking technology for progressive keratoconus. And we continue to seek to leverage our platform technologies to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies for glaucoma, corneal health, and retinal diseases.</h4> https://www.glaukos.com/

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Full time

Overview: <p><strong><u>CLINICAL SITE MONITORING</u></strong></p> <ul> <li>Travel to investigative sites to conduct site qualification, initiation, interim monitoring, and close-out visits</li> <li>Assist with selection of potential investigators</li> <li>Conduct initial and ongoing site training throughout the course of the study</li> <li>Verify informed consent process is properly followed</li> <li>Evaluate investigator compliance with the study protocol and applicable regulations</li> <li>Verify sites are collecting all required source data per protocol, accurately completing Case Report Forms, and resolving all data queries</li> <li>Review the regulatory binder and essential documents at the site and verify all documents are appropriately filed</li> <li>Verify and reconcile site&rsquo;s essential documents against the trial master file as required</li> <li>Oversee and conduct monitoring activities, including remote monitoring when applicable</li> <li>Verify investigational product is properly stored, dispensed, returned, and that accountability of the product and masking requirements are maintained throughout the study</li> </ul>
Responsibilities: <p><strong><u>CLINICAL SITE MANAGEMENT</u></strong></p> <ul> <li>Lead/manage assigned sites through regular contact with investigators and site staff to monitor progress, answer questions, and provide guidance during the course of the clinical study</li> <li>Critically review and analyze site activities through frequent visits and contacts to monitor study sites and performance</li> <li>Build relationships with the Investigators and site staff to enhance productivity, as well as collaborate with study management on protocol discrepancies, improving efficiency, and monitoring data integrity</li> <li>Manage the progress of assigned studies by tracking subject enrollment, data collection, CRF completion, source data verification, data query generation and resolution, and investigational product accountability</li> <li>Monitor subject safety and address protocol deviations, data quality issues, drug accountability, and identify process improvements for assigned sites.</li> <li>Create and maintain appropriate documentation (e.g., visit reports/letters) regarding site management, monitoring visit findings, and action plans</li> <li>Ensure audit and inspection readiness of assigned sites</li> <li>Advise on pre-audit activities for GCP requirements</li> <li>Be familiar with assigned study timelines and communicate potential issues to study management&nbsp;</li> </ul>
Requirements: <ul> <li>Works independently under direct supervision from Manager or Mentor&nbsp;&nbsp;</li> <li>0 to 2 years work experience as a regional CRA; 3 years direct clinical research experience or ophthalmology clinic experience</li> <li>Bachelor's degree in biological science, health science, nursing, health related area, or equivalent clinical experience required</li> <li>Experience in the medical device and pharmaceutical industry is preferred, and ophthalmology experience is strongly preferred for all levels of a CRA</li> <li>Knowledge and understanding of Good Clinical Practices (ICH E6 R2)</li> <li>Knowledge and understanding of FDA&rsquo;s Code of Federal Regulations applicable to conducting clinical research studies&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li> <li>Must have proficient computer skills and experience with Microsoft Office</li> <li>Must be willing and able to travel approximately 70%, including overnight, domestic and international</li> <li>Must have Self-directed behavior</li> </ul>