Glaukos

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

Glaukos • $75K — $95K *
Aliso Viejo, CA 92656In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
2 weeks ago
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in science or equivalent work experience preferred
  • 5-8 years experience as a Clinical Trials Associate in the ophthalmic field
  • Proven ability to identify and address gaps in processes
  • Understanding of clinical studies and ability to perform data cleaning
  • Experience leading meetings with internal teams and investigative sites
  • Capability to conduct site co-monitoring activities as required
  • Knowledge to support internal and external audits effectively

Responsibilities

  • Coordinate clinical research studies aligning with U.S. and international regulations
  • Develop and review clinical trial protocols and case report forms
  • Communicate effectively with clinical trial sites to facilitate the study process
  • Monitor and document errors in clinical study data, providing updates to management
  • Establish and maintain accurate Study Master Files and trackers for trial information
  • Collect site start-up documents and prepare regulatory binders for initiation visits
  • Support team functions through meeting leadership, audit facilitation, and material preparation

Benefits

  • Comprehensive health insurance
  • Retirement savings plan options
  • Opportunities for professional development and training
  • Flexible work schedule
  • Collaborative teamwork environment
Full Job Description
Job Description

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.

Qualifications

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

About Glaukos

Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent, its first MIGS device, in the United States in 2012 and is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. The company's second-generation MIGS device, the iStent inject, was approved by the FDA in June 2018. Glaukos is also developing a pipeline of innovative technologies in corneal health, including the recently acquired Microline surgical platform, as well as novel drug delivery technologies.
Learn more about Glaukos
Size
727 employees
Market Cap
$1.9 billion
Industry
Healthcare
Net Income
-$120.3 million
Founded
1998
5 Year Trend
+20.8%
Revenue
$224.9 million
NASDAQ
GKOS
* Ladders Estimates

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