Clinical Research Associate - Multiple Levels Available

Glaukos•San Clemente, CA

2d•$73,600 - $92,000

About The Position

The Clinical Research Associate (CRA) establishes and maintains the Study Master File, tracks critical trial information, and supports Regional Clinical Research Associates under the guidance of Clinical leadership. The role assesses potential study sites and supports training, on-site monitoring, closure, and management of sites participating in clinical research studies sponsored by Glaukos. The CRA maintains data integrity and monitors site conduct in accordance with applicable regulations and the study protocol. The position works independently with seldom supervision and includes substantial travel.

Requirements

Clinical coordinating experience in ophthalmology.
Knowledge and understanding of Good Clinical Practices (ICH E6 R2).
Knowledge and understanding of FDA Code of Federal Regulations applicable to conducting clinical research studies.
Proficient computer skills and experience with Microsoft Office.
Willingness and ability to travel approximately 75–80%, including overnight, domestic, and international travel.
Self-directed behavior.

Nice To Haves

Degree in biological science, nursing, or another related discipline; direct work experience may be considered.
Experience in the medical device and pharmaceutical industry.
Ophthalmology experience is strongly preferred for all levels.
Location in the Western United States is preferred.

Responsibilities

Assess the capabilities of potential study sites and assist with selecting investigators.
Travel to investigative sites to conduct qualification, initiation, interim monitoring, and close-out visits.
Conduct initial and ongoing site training throughout the study and verify that informed consent procedures are followed.
Evaluate investigator compliance with the study protocol and applicable regulations.
Verify required source data collection, accurate Case Report Form completion, and resolution of data queries.
Review site regulatory binders and essential documents, verify appropriate filing, and reconcile site documents against the trial master file as required.
Oversee and conduct monitoring activities, including remote monitoring when applicable.
Verify investigational product storage, dispensing, return, accountability, and maintenance of masking requirements.
Maintain regular contact with assigned investigators and site staff to monitor study progress, answer questions, and provide guidance.
Review and analyze site activities through visits and contacts to monitor site performance.
Build productive relationships with investigators and site staff, and collaborate with study management on protocol discrepancies, efficiency improvements, and data integrity.
Track subject enrollment, data collection, CRF completion, source data verification, data queries and their resolution, and investigational product accountability.
Monitor subject safety and address protocol deviations, data quality issues, and drug accountability; identify process improvements for assigned sites.
Create and maintain documentation such as visit reports and letters.
Mentor and train new CRAs and conduct peer-to-peer review visits.
Provide FDA inspection support.
Maintain productive relationships with investigators, site staff, and study management personnel, including assessing and resolving relationship issues.
Participate in developing source document templates, CRFs, CRF completion guidelines, and monitoring plans.
Execute department projects.