Glaukos San Diego , CA 92140
Posted 5 days ago
How will you make an impact?
The 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 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
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
How will you get here?
2-5 years' work experience with data entry, and clinical research industry, 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) helpful
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.
Glaukos