Clinical Trials Associate - Multiple Levels Available

How will you make an impact?

The Clinical Trials Associate/CTAII/ SR CTA/SR CTAII/Principal CTA 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

• 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

How will you get here?

CTA

• Bachelor's Degree with background in science or equivalent work experience preferred
• 2 years of work experience as a CTA
• Understanding of required regulatory documents for the study
• Effective communication and understanding of the role with sites; with both

CTA II

• Bachelor's Degree with background in science, or equivalent work experience
• 2-5 years clinical work experience in the pharmaceutical or device industry, preferably within the ophthalmology field
• 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

Senior CTA

• Bachelor's Degree with background in science or equivalent work experience
• 4-8 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

Senior CTAII

• Bachelor's Degree required
• 8-12 years of work experiences as CTA in ophthalmic field
• 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.

Principal:

• Bachelor's Degree with background in science or equivalent work experience
• 12+ years of experience as a CTA in ophthalmic field
• Principal CTA must demonstrate the following:
• Specific expertise within department i.e. mentor / train new CTAs.
• May lead projects or project module.
• Make presentations internally and for investigative sites.
• Able to perform site monitoring activities as needed.
• 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

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.