Glaukos Corporation
Clinical Trial Associate II - Onsite in Aliso Viejo, CA
Glaukos Corporation, Aliso Viejo, California, United States, 92656
Job DescriptionHow you will make an impact:The Clinical Trials Associate II is responsible for the coordination of clinical research studies in compliance with U.S. and international regulations under the guidance of a Clinical Manager or Clinical Director.What you will you:Clinical Study Preparation and Maintenance Assists with review of clinical trial protocols Assists with development/review of source documents Assists with preparation of Informed Consent Forms Assists with development of recruitment materials and study tools Works with cross functional team members as assigned Works with study vendors as assignedCollection and Review of Site Start-Up Documents Communicates directly with site staff to obtain site start-up documents Negotiates study contract and budget Prepares Regulatory Binders and provides to sites prior to Site Initiation Visit (SIV)Receives, QC's, and files site documents in Study Master File Provides status of site documents in Study Master File to Clinical Research Associates (CRAs) prior to Monitoring VisitsClinical Site Management CTA is responsible for effective communication with clinical trial sites Obtains site documents from Clinical Research Associates during trial Addresses inquiries from sites and CRAs Escalates issues to study management as neededStudy Master File Maintenance Sets up Study Master File and Study Master File Tracker at the beginning of each study Receives, QC's, scans and files documents in Study Master File Provides status of documents to Clinical ManagementEstablishes and Maintains Tracking of Trial Information Team and site contact information Site status information Equipment and supplies Enrollment trackers Adverse event trackers Site payment trackers and site paymentsHow You'll Get There: Bachelor's Degree with background in science, or equivalent work experience preferred 2-5 years recent clinical work experience in the bio- pharmaceutical or device industry, preferably within the ophthalmology field About UsGenerous. Innovative. Leadership-driven. Family-oriented. Socially responsible. Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases. Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients. Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra "We'll Go First," which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do. Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol "GKOS". Our global headquarters is in Aliso Viejo, California with additional locations in San Clemente, California, and Burlington, Massachusetts.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.