Glaukos Corporation · 1 day ago
Clinical Research Associate II
United States
Full-time
Remote
Mid, Senior Level
5+ years expGlaukos Corporation is a company focused on advancing the treatment of eye diseases, and they are seeking a Clinical Research Associate II to manage and monitor clinical research studies. The role involves assessing study sites, training site staff, and ensuring compliance with study protocols and regulations while maintaining data integrity.
Health CareMedicalWellness
Responsibilities
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
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) regarding site management, monitoring visit findings, and action plans
Ensure audit and inspection readiness of assigned sites
Advise on pre-audit activities for GCP requirements
Be familiar with assigned study timelines and communicate potential issues to study management
Qualification
Required
2 to 5 years work experience as a regional CRA
5 years direct clinical research experience
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 75-80%, including overnight, domestic and international
Must have Self-directed behavior
Preferred
Experience in the medical device and pharmaceutical industry
Ophthalmology experience is strongly preferred for all levels of a CRA
Company
Glaukos Corporation
At Glaukos, our focus is to develop and lead the global ophthalmic market with novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases—therapies that advance the existing standard of care and enrich the lives and treatment alternatives for patients worldwide.
1001-5000 employees
H1B Sponsorship
Glaukos Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (6)
2023 (1)
2022 (3)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$121MKey Investors
Meritech Capital PartnersOrbiMed
2015-06-25IPO
2013-02-07Series F· $30M
2012-10-03Debt Financing· $6M
Leadership Team
Alex Thurman
Senior Vice President and Chief Financial Officer
Joseph Gilliam
President & Chief Operating Officer
Recent News
2025-12-17
Orange County Business Journal
2025-11-09
Company data provided by crunchbase