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Clinical Trials Associate II
Job
Glaukos Corporation
Aliso Viejo, CA (In Person)
Full-Time
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Job Description
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.
- Bachelor's Degree with background in science, or equivalent work experience Preferred
- 2-5 years clinical work experience in the bio
- pharmaceutical or device industry, preferably within the ophthalmology field Required
- CTA must demonstrate the following:
- Understanding of required regulatory documents for the study.
- Effective communication and understanding of the role with sites; with both monitors and CRMs. Required Clinical Trials Coordination
- 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 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
- 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
- Support IP shipment and shipment of other materials to sites #GKOSUS