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 SR. 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
- Must have Self-directed behavior
- Ideally will be located in Western US
#GKOSUS
Job Tags
Work experience placement, Interim role, Work at office, Remote work, Night shift