Clinical Research Associate II

Glaukos Corporation

About The Position

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.

Requirements

Works independently with minimal supervision
Conducts all types of site visits
Build strong productive relationships with study investigators, site staff, and study management personnel
Participates in department projects 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

Nice To Haves

Experience in the medical device and pharmaceutical industry is preferred, and ophthalmology experience is strongly preferred for all levels of a CRA

Responsibilities

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
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