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

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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