Glaukos Corporation
Senior Clinical Research Associate
Glaukos Corporation, San Clemente, California, us, 92674
How will you make an impact?
The Sr. Clinical Research Associate (CRA) is responsible for establishing and maintaining the Study Master File, tracks critical trial information, and supports Regional Clinical Research Associates under the guidance of a Clinical Manager or Clinical Director.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 ManagementCollection 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 VisitsEstablishes 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 paymentsTeam 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 sitesHow will you get here?* 6 plus years' work experience clinical research industry, monitoring, preferably within the ophthalmology field.* Familiarity with clinical trials study documentation* Accurate data entry experience* Excellent problem solving and analytical skills (ability to interpret and summarize data, perform statistics)* Excellent written and verbal communication and presentation skills* Motivated and able to work independently, as well as within a team* Excellent organizational skills* Medical terminology (and ophthalmology terminology) helpful* Exhibits personal integrity, credibility, and responsibility* Meets milestones and schedules* Collaborates with other team members and demonstrates good interpersonal skills* Demonstrates initiative, independence, and organization in work tasks* Knowledge of FDA's Good Clinical Practices guidelines, clinical trial monitoring and regulatory compliance* Knowledge of International Clinical Research Standards (ISO, ICH, etc.)* Demonstrates proficiency in study monitoring and auditing* Must be willing to travel up to 80% of the time (estimated)* Medical terminology (and ophthalmology terminology) helpfulGenerous. 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.
The Sr. Clinical Research Associate (CRA) is responsible for establishing and maintaining the Study Master File, tracks critical trial information, and supports Regional Clinical Research Associates under the guidance of a Clinical Manager or Clinical Director.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 ManagementCollection 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 VisitsEstablishes 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 paymentsTeam 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 sitesHow will you get here?* 6 plus years' work experience clinical research industry, monitoring, preferably within the ophthalmology field.* Familiarity with clinical trials study documentation* Accurate data entry experience* Excellent problem solving and analytical skills (ability to interpret and summarize data, perform statistics)* Excellent written and verbal communication and presentation skills* Motivated and able to work independently, as well as within a team* Excellent organizational skills* Medical terminology (and ophthalmology terminology) helpful* Exhibits personal integrity, credibility, and responsibility* Meets milestones and schedules* Collaborates with other team members and demonstrates good interpersonal skills* Demonstrates initiative, independence, and organization in work tasks* Knowledge of FDA's Good Clinical Practices guidelines, clinical trial monitoring and regulatory compliance* Knowledge of International Clinical Research Standards (ISO, ICH, etc.)* Demonstrates proficiency in study monitoring and auditing* Must be willing to travel up to 80% of the time (estimated)* Medical terminology (and ophthalmology terminology) helpfulGenerous. 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.