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

Glaukos

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. https://www.glaukos.com/

keywords: research,training,management,assist,prepare,scheduling,deliver,research,experience,knowledge,presentation,performance,management,teamwork,degree,assist,technology,travel,support,professional

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>