Trial Master File Associate Jobs in California (NOW HIRING)

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.

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.

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