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

Glaukos Corporation • Aliso Viejo, CA

1d • Onsite

About The Position

The Sr. 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
• 5-8 years of work experiences as CTA in ophthalmic field required
• Sr. CTA must demonstrate the following: May have specific expertise i.e. systems subject matter expert, regulatory knowledge.
• Ability to identify gaps and address them.
• Understanding of the studies assigned; for instance can perform data cleaning.
• Leading meetings internally and for investigative sites.
• Able to perform site co-monitoring activities as needed.
• Support internal and external audits required

Responsibilities

• Integral part of development of clinical trial protocols
• Reviews clinical study data
• Development of case report forms
• CTA is responsible for effective communication with clinical trial sites
• Uses gained experience to give high level analyses of study data
• Reviews and Monitors Clinical Study Data
• Reviews complex data as it comes in from sites
• Documents errors and communicates to Manager and Director Clinical Operations
• Communicates with sites to correct errors
• Works with Manager with study management
• Sets up Study Master File and Study Master File Tracker at the beginning of each study
• Receives, 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, 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
• Leads meetings internally and for investigative sites.
• Perform site co-monitoring activities as needed.
• Supports internal and external audits.
• 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: Senior