Clinical Trials Coordinator
Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on the development and commercialization of novel surgical devices and sustained pharmaceutical therapies designed to transform the treatment of glaucoma, one of the world’s leading causes of blindness.
The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, in order to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent®, its first MIGS device, in the United States in 2012 and is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression.
The company’s second-generation MIGS device, the iStent inject® Trabecular Micro-Bypass System, was approved by the Food and Drug Administration, or FDA in June 2018. The company believes the iStent inject,® measuring 0.23 mm wide and 0.36 mm long, is the smallest medical device ever approved by the FDA.
In June 2015, Glaukos completed an initial public offering and our shares are now traded on the New York Stock Exchange under the ticker symbol “GKOS”. The company was founded in 1998 and is based in San Clemente, California.
The Clinical Trials Coordinator, based in San Clemente, California, supports the administrative aspects of the Clinical Research and Medical Affairs teams.
Clinical Research Department Support:
• Coordinate, plan, and schedule meetings and events as needed
• Act as meeting facilitator and minute’s taker as needed
• Assist with ordering Office supplies and creating requisitions for orders when required
• Assist with editing and reviewing major conference PowerPoint presentations as needed
• Serve as the point of contact to Facilities and IT Department, responsible for the upkeep and maintenance of the Clinical copiers.
• Assemble binders for trainings, meetings, projects, and other needs
• Create and manage the Clinical Compendium
• Prepare expense reports as needed
Clinical Research Study Team Support:
• Provide project support for the Clinical Research teams on varies projects and tasks as needed:
• Assist with site selection (e.g., NDA execution, Feasibility Questionnaire collection, etc.)
• Assist with Study Start-Up Tasks
• Manage supply and shipping projects
• Assist with Data Review projects
• Manage and Update Contact Lists
• Manage UBM Scheduling as needed
• Assist with FDA inspections as back-room support
• Assist in TMF filing and upkeep
• Communicate and send study supplies to sites as needed
• Handle the execution of Clinical NDAs and Outreach Program Agreements
• Prepare and submit Outreach Agreement Payment requests
• Manage inventory and shipping needs for the EIR program
• Upload Clinical contracts into Agiloft
• Act as system Administrator for DocuSign and FedEx
Department may assign or require other duties as needed by the business.
· Excellent problem solving and analytical skills
· Excellent written and verbal communication and presentation skills
· Excellent organizational and planning skills
· Expert Level MS Office skills with an emphasis on MS Excel and PowerPoint
Bachelor’s degree required with 0 to 2 years related experience
We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class. Check out our profile on The Muse to get an inside look at our company culture.
Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.