Job Description
We are a medical technology and pharmaceutical company that's advancing the treatment of ophthalmic diseases. At Glaukos, we are pioneering new treatments for chronic eye diseases and are focused on novel therapies for the treatment of glaucoma (market-leader iStent inject® W), corneal disorders and retinal diseases. We have an amazing culture that fosters opportunities for growth, excellent benefits, great pay, and are Great Place to Work Certified.
We're looking for a Sr. Clinical Research Associate to join our team. This is an opportunity to be part of a team that takes pride in leading the way in our business and our community - we dare to dream, dare to lead, and dare to care. If you want to be part of this exciting work, you belong at Glaukos!
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How will you make an impact?
The Clinical Research Associate (CRA) is 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
- Oversee and conduct monitoring activities.
- 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.
- Verify and reconcile site's essential documents against the trial master file.
- Verify investigational product is properly stored, dispensed, returned.
- Guide/manage assigned sites.
- Critically review and access site activities.
- Build relationships with the Investigators and site staff. 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, and drug accountability.
- Create and maintain appropriate documentation (e.g., visit reports/letters) regarding site management, monitoring visit findings, and action plans.
- Ensure audit and inspection readiness.
- Advise on pre-audit activities for GCP requirements.
- 5 years of work experience as a regional CRA; 8 years direct clinical research experience
- Minimal supervision.
- Mentor/train new CRAs.
- Provide FDA inspection support.
- Maintain strong productive relationships with study investigators, site staff, and study management personnel.
- Participate in the development of source document templates, CRFs, CRF completion guidelines, and monitoring.
- Bachelor's degree in biological science, health science, nursing, health related area, or equivalent clinical experience required.
- Knowledge of Good Clinical Practices (ICH E6 R2).
- Knowledge of FDA's Code of Federal Regulations applicable to conducting clinical research studies.
- Proficient computer skills and experience with Microsoft Office
- Travel approximately 70%, including overnight, domestic and international.
- Experience in the medical device and pharmaceutical industry is preferred.
- Ophthalmology experience is strongly preferred for all levels of a CRA.
$94,800 - $123,300. (plus bonus , equity etc.)
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.