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

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
• High school Diploma; plus 2 years' experience in a clerical-supportive role or work experience as detailed above.