Clinical Trial Associate II - Onsite in Aliso Viejo, CA

How will you make an impact?

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.

What will you do?

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
• 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, 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

How will you get here?

• Minimum of 2 years of work experience as CTA in ophthalmic field
• 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.
• Bachelor's degree with background in science preferred, or equivalent work experience

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

These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family.

Those may seem like big aspirations, but here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve eyesight of people worldwide. And because we're a rapidly growing company with a dynamic, fast-paced culture, individual employees are empowered with more diverse and enriching challenges that might not be possible at a larger company, and more fulfillment in knowing every person and every task is directly tied to making a difference in the life of others.

We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, generous time off & paid holidays as well as time-off to volunteer in the community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class! Moreover, Glaukos Corporation has been Certified as a Great Place to Work the last three years!

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.