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

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.

What You'll Do: 

• 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, QC8217;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, 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
• 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

How You'll Get there: 

• Bachelor's Degree with background in science, or equivalent work experience Preferred
• CTA1 - 1-2 years experience (Salary Range - 69,000. - 83,500.)
• CTAII 2-5 years clinical work experience in the bio- pharmaceutical or device industry, preferably within the ophthalmology field (posted)
• Sr. CTA 5 plus years experience, ophthalmology experience strongly preferred (Salary Range - 107,700 - 134,600)
• 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