Clinical Trials Associate 1, 2 or Sr. - Onsite in Aliso Viejo, CA

Glaukos Corporation • San Clemente, CA

11d • Onsite

About The Position

The Clinical Trials Associate II 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
• Understanding of required regulatory documents for the study.
• Effective communication and understanding of the role with sites; with both monitors and CRMs

Nice To Haves

• CTAII 2-5 years clinical work experience in the bio- pharmaceutical or device industry, preferably within the ophthalmology field
• Sr. CTA 5 plus years experience, ophthalmology experience strongly preferred

Responsibilities

• Assists with the development of clinical trial protocols
• Reviews clinical study data
• Assists with development of case report forms
• CTA is responsible for effective communication with clinical trial sites
• Analyses of study data with support of more experience CTAs or manager
• Reviews data as it comes in from sites
• Documents errors and communicates to Manager and Director Clinical Operations
• Communicates with sites to correct errors
• Assists Manager with study management
• Sets up Study Master File and Study Master File Tracker at the beginning of each study
• Receives, QC8217;s, scans and files documents in Study Master File
• Provides status of documents to Clinical Management
• 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, QC8217;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
• Team and site contact information
• Site status information
• Enrollment trackers
• Adverse event trackers
• Site payment trackers and site payments
• Schedules meetings, set up of AV, teleconference or video conference equipment
• Preparation of relevant materials
• Support IP shipment and shipment of other materials to sites

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 251-500 employees