Job Description
How will you make an impact?
What will you do?
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
- 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
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- Team and site contact information
- Site status information
- Enrollment trackers
- Adverse event trackers
- Site payment trackers and site payments
- 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
- 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
- High school Diploma; plus 2 years' experience in a clerical-supportive role or work experience as detailed above.
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.