Glaukos

Sr. Clinical Trials Associate

Glaukos • $80K — $95K *
Aliso Viejo, CA 92656In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in a science-related field or equivalent experience.
  • At least 4 years of relevant work experience as a Clinical Trials Associate (CTA).
  • Strong grasp of regulatory documents necessary for clinical studies.
  • Excellent communication skills with clinical trial sites.
  • Ability to resolve issues and document errors effectively.

Responsibilities

  • Coordinate clinical research studies under supervision of Clinical Manager or Director.
  • Assist in developing clinical trial protocols and case report forms.
  • Review and monitor incoming clinical study data for accuracy.
  • Maintain the Study Master File and ensure document quality control.
  • Communicate with site staff to gather necessary start-up documents.
  • Track and manage key trial information, including enrollment and adverse events.
  • Provide logistical support for meetings and material preparation.

Benefits

  • Opportunity to work on impactful clinical trials.
  • Exposure to both U.S. and international regulatory standards.
  • Development and growth opportunities in clinical research.
  • Collaborative and supportive team 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.

Responsibilities

  • Clinical Trials Coordination
    * Supports 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
    * Assists with analyses of study data
  • Reviews and Monitors Clinical Study Data
    * Reviews data as it comes in from sites
    * Documents errors and communicates to Manager
    * 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
    * Scheduling meetings, set up of AV, teleconference or video conference equipment
    * Preparation of relevant materials
    * Support IP shipment and shipment of other materials to sites


Qualifications

- Bachelor's Degree with background in science or equivalent work experience Preferred

SR. CTA 4 plus years of work experience as a CTA

- CTA must demonstrate the following: • Understanding of required regulatory documents for the study. • Effective communication and understanding of the role with sites; with both

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

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Glaukos

More Pharmaceuticals & Biotech Jobs

Find similar Sr. Clinical Trials Associate jobs:

NationwideAliso Viejo, CA