Clinical Trials Associate - Multiple Levels

Glaukos Corporation • Aliso Viejo, CA

2d

About The Position

The Clinical Trials Associate is responsible for the coordination of clinical research studies in compliance with U.S. and international regulations under the guidance of a Clinical Manager or Clinical Director.

Requirements

• Bachelor's Degree with background in science, or equivalent work experience preferred
• 2 or more years clinical work experience in the bio- pharmaceutical or device industry, preferably within the ophthalmology field
• Understanding of required regulatory documents for the study.
• Effective communication and understanding of the role with sites; with both monitors and CRMs.
• Study start up/site initiation experience a must

Responsibilities

• Clinical Trials Coordination: Assists with the development of clinical trial protocols, reviews clinical study data, assists with development of case report forms, and is responsible for effective communication with clinical trial sites. Analyzes study data with support of more experienced CTAs or manager.
• Reviews and Monitors Clinical Study Data: Reviews data as it comes in from sites, documents errors, and communicates to Manager and Director.
• Clinical Operations: Communicates with sites to correct errors and assists Manager with study management.
• Study Master File Maintenance: Sets up Study Master File and Study Master File Tracker at the beginning of each study. Receives, QC’s, scans and files documents in Study Master File. Provides status of documents to Clinical Management.
• Collection of Site Start-Up Documents: Communicates directly with site staff to obtain site start-up documents. Prepares Regulatory Binders and provides to sites prior to Site Initiation Visit (SIV). Obtains site documents from Regional Clinical Research Associates during trial. Receives, QC’s, scans, and files site documents in Study Master File. Provides status of site documents in Study Master File to Regional Clinical Research Associates prior to Monitoring Visits.
• Establishes and Maintains Tracking of Critical Trial Information: Team and site contact information, site status information, enrollment trackers, adverse event trackers, site payment trackers and site payments.
• Team Support: Schedules meetings, set up of AV, teleconference or video conference equipment, preparation of relevant materials, and support IP shipment and shipment of other materials to sites.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level