Job Description
How will you make an impact?

Responsible for assessing the study capabilities of potential study sites, training, on-site monitoring, closure, and management of sites participating in clinical research studies sponsored by Glaukos. The Clinical Research Associate (CRA) is responsible for maintaining data integrity and monitoring study conduct in accordance with regulations and the study protocol at the site level.

What will you do?

CLINICAL SITE MONITORING

• Travel to investigative sites to conduct site qualification, initiation, interim monitoring, and close-out visits
• Assist with selection of potential investigators
• Conduct initial and ongoing site training throughout the course of the study
• Verify informed consent process is properly followed
• Evaluate investigator compliance with the study protocol and applicable regulations
• Verify sites are collecting all required source data per protocol, accurately completing Case Report Forms, and resolving all data queries
• Review the regulatory binder and essential documents at the site and verify all documents are appropriately filed
• Verify and reconcile site's essential documents against the trial master file as required
• Oversee and conduct monitoring activities, including remote monitoring when applicable
• Verify investigational product is properly stored, dispensed, returned, and that accountability of the product and masking requirements are maintained throughout the study

CLINICAL SITE MANAGEMENT

• Lead/manage assigned sites through regular contact with investigators and site staff to monitor progress, answer questions, and provide guidance during the course of the clinical study
• Critically review and analyze site activities through frequent visits and contacts to monitor study sites and performance
• Build relationships with the Investigators and site staff to enhance productivity, as well as collaborate with study management on protocol discrepancies, improving efficiency, and monitoring data integrity
• Manage the progress of assigned studies by tracking subject enrollment, data collection, CRF completion, source data verification, data query generation and resolution, and investigational product accountability
• Monitor subject safety and address protocol deviations, data quality issues, drug accountability, and identify process improvements for assigned sites.
• Create and maintain appropriate documentation (e.g., visit reports/letters)

How will you get here?

• Works independently with seldom supervision
• Mentor/train new CRAs
• Conduct peer to peer review visits
• Provide FDA inspection support
• Maintain strong productive relationships with study investigators, site staff, and study management personnel, including assessment and resolution of existing relationship issues
• Participate in the development of source document templates, CRFs, CRF completion guidelines, monitoring plans, etc.Executes department projects
• 5 years' work experience as a regional CRA; 8 years direct clinical research experience
• Bachelor's degree in biological science, nursing, or other related discipline preferred, or direct work experience as detailed below.
• Experience in the medical device and pharmaceutical industry is preferred, and ophthalmology experience is strongly preferred for all levels of a CRA Knowledge and understanding of Good Clinical Practices (ICH E6 R2)
• Knowledge and understanding of FDA's Code of Federal Regulations applicable to conducting clinical research studies
• Must have proficient computer skills and experience with Microsoft Office
• Must be willing and able to travel approximately 70%, including overnight, domestic and international
• Must have Self-directed behavior

Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.
These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family.
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'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.
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 & 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, Glaukos Corporation has been Certified as a Great Place to Work the last three years!
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.

#GKOSUS

About Us
Generous. 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.