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Clinical Research Associate 1/11 - Ophthalmology Experience
Clinical Research Associate 1/11 - Ophthalmology ExperienceGlaukos Corporation • San Clemente, CA, United States
Clinical Research Associate 1 / 11 - Ophthalmology Experience

Clinical Research Associate 1 / 11 - Ophthalmology Experience

Glaukos Corporation • San Clemente, CA, United States
17 days ago
Job type
  • Full-time
Job description

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.

What will you do?

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?

  • CRA1 - Minimum of one year experience as a clinical coordinator within the ophthalmology field. 62,300 - 81,000
  • CRAII - Minimum of 2 years experience in monitoring, with ophthalmology experience 82,500-107,000
  • SR CRA - Minimum of 4 years monitoring experience in the medical device or pharma industry with experience in ophthalmology. At least 7 years direct clinical research experience. 109,000-141,000.
  • Excellent comprehensive financial package including bonus, vacation, benefits and more!
  • #GKOSUS

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    Clinical Research Associate • San Clemente, CA, United States

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