Clinical Research Associate Training Manager

<strong>At Glaukos, our focus is to develop and lead the global ophthalmic market with novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases&mdash;therapies that advance the existing standard of care and enrich the lives and treatment alternatives for patients worldwide.<br /><br />Help put the next wave of disruptive technologies on the market. Work with a team that&rsquo;s dedicated to making a difference in the lives of patients worldwide.<br /></strong>

Aliso Viejo, CA


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. <br /><br />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.<br /><br />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.

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Full time

Overview: The Clinical Research Associate Training Manager will be responsible for managing, organizing and conducting Clinical Research Associate training. &nbsp;The Clinical Research Associate Training Manager may be assigned Clinical Site Monitoring and Management activities in the range of 25%-50% of total time. &nbsp;The position can be &nbsp;remote any where within U.S. preference: California, Texas.
Responsibilities: <p><strong><u>Primary owner and driver of Clinical Research Associate (CRA) Training:</u></strong></p> <ul> <li>Manage, organize, and deliver CRA training which includes but is not limited to: <ul> <li><strong><u>CRA New Hire Training</u></strong> <ul> <li>Developing CRA new hire training guidelines and presentations</li> <li>Preparing CRA new hire training materials</li> <li>Scheduling and delivery of CRA new hire training</li> <li>Filing and tracking CRA new hire training documentation</li> <li>Coordinating Clinical Systems training (e.g. CTMS and eTMF) for new hires</li> <li>&nbsp;</li> </ul> </li> <li><strong><u>Ongoing CRA Team Training:</u></strong> <ul> <li>Monitoring Methods</li> <li>Procedures</li> <li>Forms and Templates</li> <li>Process Changes</li> <li>Guidance and Regulation Changes</li> </ul> </li> </ul> </li> <li>Assist with CRA new hire onboarding: <ul> <li>Manages and schedules CRA new hire observation visits and sign-off visits</li> <li>Partners with CRA Management to schedule protocol specific training for assigned studies</li> </ul> </li> <li>Creates and delivers modified CRA new hiring training for contract CRAs utilized outside of the United States</li> <li>Mentors/trains CRAs and clinical staff, including assessment of monitoring skills by traveling with the CRA to a site visit</li> <li>Works in partnership with CRA Management to identify training gaps for individual CRAs and / or the CRA team as a whole</li> <li>Assists with creation and / or review of CRA forms, tools and template</li> </ul>
Requirements: <p><strong><u>Conduct Clinical Site Monitoring and Site Management Activities for Assigned Sites (Approximately 25%):</u></strong></p> <ul> <li>Bachelor&rsquo;s Degree preferred or equivalent strong Clinical Research and / or Ophthalmology experience.</li> <li>8+ years of Clinical Research experience with at least 4 years work experience as a Clinical Research Associate</li> <li>Perform monitoring activities for assigned protocols / sites</li> <li>Assist with monitoring and other site support as needed to meet deadlines or reduce backlog</li> <li>Provide site support in preparation of audits</li> </ul> <p>&nbsp;</p> <ul> <li>Strong public speaking / presentation skills and the ability to train others</li> <li>Ability to work independently, take initiative, and have a flexible approach with respect to work assignments</li> <li>Experience in the medical device and pharmaceutical industry is preferred, and ophthalmology experience is strongly preferred</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;</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>Ability to demonstrate and foster teamwork within the group as well as at the clinical sites.</li> </ul>