Glaukos Corporation

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

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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

#GKOSUS

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