Clinical Research Associate II

<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> <br /><br />Base Salary Range: $82,500 - $107,200

Los Angeles, CA


<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>

keywords: position summary,compensation,research,teamwork,management,scheduling,assist,support,knowledge,skills,education,experience,travel

Full time

Base Salary Range: $82,500 - $107,200

Overview: The Clinical Research Associate (CRA) is responsible for establishing and maintaining the Study Master File, tracks critical trial information, and supports Regional Clinical Research Associates under the guidance of a Clinical Manager or Clinical Director.
Responsibilities: <p><strong>Study Master File Maintenance</strong></p> <ul> <li>Sets up Study Master File and Study Master File Tracker at the beginning of each study</li> <li>Receives, QC&rsquo;s, scans and files documents in Study Master File</li> <li>Provides status of documents to Clinical Management</li> </ul> <p><strong>Collection of Site Start-Up Documents</strong></p> <ul> <li>Communicates directly with site staff to obtain site start-up documents</li> <li>Prepares Regulatory Binders and provides to sites prior to Site Initiation Visit (SIV)</li> <li>Obtains site documents from Regional Clinical Research Associates during trial</li> <li>Receives, QC&rsquo;s, scans and files site documents in Study Master File</li> <li>Provides status of site documents in Study Master File to Regional Clinical Research Associates prior to Monitoring Visits</li> </ul> <p><strong>Establishes and Maintains Tracking of Critical Trial Information</strong></p> <ul> <li>Team and site contact information</li> <li>Site status information</li> <li>Enrollment trackers</li> <li>Adverse event trackers</li> <li>Site payment trackers and site payments</li> </ul> <p><strong>Team Support</strong></p> <ul> <li>Participates in clinical team meetings and may prepare minutes</li> <li>May assist with meeting logistics, events and training, including Investigator Meetings</li> <li>Scheduling meetings, set up of AV, teleconference or video conference equipment</li> <li>Preparation of relevant materials</li> <li>Support IP shipment and shipment of other materials to sites</li> </ul>
Requirements: <ul> <li>2-5 years' work experience with data entry, and clinical research industry, preferably within the ophthalmology field.&nbsp;</li> <li>Familiarity with clinical trials study documentation&nbsp;</li> <li>Accurate data entry experience&nbsp;</li> <li>Excellent problem solving and analytical skills (ability to interpret and summarize data, perform statistics)&nbsp;</li> <li>Excellent written and verbal communication and presentation skills&nbsp;</li> <li>Motivated and able to work independently, as well as within a team&nbsp;</li> <li>Excellent organizational skills&nbsp;</li> <li>Medical terminology (and ophthalmology terminology) helpful&nbsp;</li> <li>Exhibits personal integrity, credibility, and responsibility&nbsp;</li> <li>Meets milestones and schedules&nbsp;</li> <li>Collaborates with other team members and demonstrates good interpersonal skills&nbsp;</li> <li>Demonstrates initiative, independence, and organization in work tasks&nbsp;</li> <li>Knowledge of FDA&rsquo;s Good Clinical Practices guidelines, clinical trial monitoring and regulatory compliance&nbsp;</li> <li>Knowledge of International Clinical Research Standards (ISO, ICH, etc.)&nbsp;</li> <li>Demonstrates proficiency in study monitoring and auditing&nbsp;</li> <li>Must be willing to travel up to 80% of the time (estimated)&nbsp;</li> <li>Medical terminology (and ophthalmology terminology) helpful&nbsp;</li> <li>High school Diploma; plus 2 years&rsquo; experience in a clerical-supportive role or work experience as detailed above.​&nbsp;</li> </ul> <br /> <p><strong>Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.</strong>&nbsp;</p> <p>These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family.</p> <p>Those may seem like big aspirations, but 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 eyesight of people worldwide. And because we&rsquo;re a rapidly growing company with a dynamic, fast-paced culture, individual employees are empowered with more diverse and enriching challenges that might not be possible at a larger company, and more fulfillment in knowing every person and every task is directly tied to making a difference in the life of others.</p> <p>We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, generous time off &amp; paid holidays as well as time-off to volunteer in the community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class! Moreover,&nbsp;Glaukos Corporation has been Certified as a Great Place to Work the last&nbsp;three years!</p> <p>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.</p>