Clinical Trials Associate II

Job Description

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.

Responsibilities

• 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, 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
  * 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

#GKOSUS

Qualifications

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

- 2-5 years clinical work experience in the bio- pharmaceutical or device industry, preferably within the ophthalmology field Required

- 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. Required

About Us

Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.

Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.

Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases.

Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients.

Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra "We'll Go First," which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do.

Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol "GKOS". Our global headquarters is in Aliso Viejo, California with additional locations in San Clemente, California, and Burlington, Massachusetts.

Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

All offers of employment are contingent upon the successful completion of a background check, including successfully passing a drug screen, based on the position and local regulations.