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

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.

What You’ll Do:

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.

• Clinical Trials Coordination
  * 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
• Study Master File Maintenance
  * 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
• 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, 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
  * 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

How You’ll Get There:

• 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

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