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Clinical Research Associate - Western United States
The CRA is responsible for assessing, training, and monitoring clinical research sites to ensure data integrity and protocol compliance. This includes conducting site visits, managing investigator relationships, and overseeing the accountability of investigational products.
Requirements summary
Requires clinical coordinating experience in ophthalmology and a degree in biological science, nursing, or a related field. Candidates must be proficient in ICH GCP and FDA regulations and be willing to travel 75-80% of the time.
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
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)
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
How will you get here?
Clinical coordinating experience in ophthalmology required
Degree in biological science, nursing, or other related discipline preferred, or direct work experience
Experience medical device and pharmaceutical industry is preferred, and ophthalmology experience is strongly preferred for all levels
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
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.
All offers of employment are contingent upon the successful completion of a background check, including successfully passing a drug screen, based on the position and local regulations.
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