Clinical Trials Associate

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Glaukos is an equal opportunity employer and makes employment decisions on the basis of merit. Glaukos participates in E-Verify. The Company policy prohibits discrimination based on race, color, creed, gender, gender identity, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, genetic information, sexual orientation, covered veteran status, or any other consideration made unlawful by applicable federal, state, or local laws. It also prohibits unlawful discrimination based on the perception that anyone has any of those characteristics, or is associated with a person who has or is perceived as having any of those characteristics.

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Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our 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. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide. 

Position Overview:

The Clinical Trials Associate, based in San Clemente, California, 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 Trial Coordination

•               Assists with the development of clinical trial protocols

•               Reviews clinical study data

•               Assists with development of case report forms

•               Communicates 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 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, QCs, 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

•               Participates in clinical team meetings and may prepare minutes

•               May assist with meeting logistics, events and training, including Investigator Meetings

•               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

Work Experience:   

CTA - At least 3-5 years of work experience as a CTA

Senior CTA – 5 years of work experiences as CTA in ophthalmic field

 ·               Familiarity with clinical trials study documentation

·               Excellent problem solving and analytical skills (ability to interpret and summarize data, perform basic statistics)

·               Excellent written and verbal communication and presentation skills

·               Motivated and able to work independently, as well as within a team

·               Excellent organizational skills

Education:

  • Bachelor's degree with background in sciences preferred

We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class. Check out our profile on The Muse to get an inside look at our company culture: https://www.themuse.com/companies/glaukoscorporation

Glaukos has been recognized by the Orange County Business Journal as one of the best companies to work for in in Orange County, check out page 8 at http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf 

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.

 

 

 

Location: Clinical Affairs in San Clemente, CA
Apply for this Position
Apply at: https://glaukos.synchr-recruit.com/job/87682/clinical-trials-associate