Sr. CTA
Apply NowCompany: Glaukos
Location: Aliso Viejo, CA 92656
Description:
Job Description
How will you make an impact?
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.
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
Sr. CTA and above leading meetings internally and for investigative sites.
Sr. CTA able to perform site co-monitoring activities as needed.
Sr. CTA supports internal and external audits.
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 5 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.
#GKOSUS
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.
How will you make an impact?
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.
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
Sr. CTA and above leading meetings internally and for investigative sites.
Sr. CTA able to perform site co-monitoring activities as needed.
Sr. CTA supports internal and external audits.
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 5 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.
#GKOSUS
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.