Clinical Research Associate - Multiple Levels Available

The Clinical Research Associate (CRA) is responsible for establishing and maintaining the Study Master File, tracks critical trial information, and supports Regional Clinical Research Associates under the guidance of a Clinical leadership

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

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

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