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 documentsPrepares Regulatory Binders and provides to sites prior to Site Initiation Visit (SIV)Obtains site documents from Regional Clinical Research Associates during trialReceives, QC's, scans and files site documents in Study Master FileProvides 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 informationSite status informationEnrollment trackersAdverse event trackersSite payment trackers and site paymentsTeam Support
Participates in clinical team meetings and may prepare minutesMay assist with meeting logistics, events and training, including Investigator MeetingsScheduling meetings, set up of AV, teleconference or video conference equipmentPreparation of relevant materialsSupport IP shipment and shipment of other materials to sitesHow will you get here?
CRA1 - Minimum of one year experience as a clinical coordinator within the ophthalmology field. 62,300 - 81,000CRAII - Minimum of 2 years experience in monitoring, with ophthalmology experience 82,500-107,000SR 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