Clinical Trials Associate II - Onsite in Aliso Viejo

How you will make an impact:

The Clinical Trials Associate II is responsible for the coordination of clinical research studies in compliance with U.S. and international regulations under the guidance of a Clinical Manager or Clinical Director.

What you will you:

Clinical Study Preparation and Maintenance

• Assists with review of clinical trial protocols
• Assists with development/review of source documents 
• Assists with preparation of Informed Consent Forms
• Assists with development of recruitment materials and study tools
• Works with cross functional team members as assigned
• Works with study vendors as assigned

Collection and Review of Site Start-Up Documents

• Communicates directly with site staff to obtain site start-up documents
• Negotiates study contract and budget
• Prepares Regulatory Binders and provides to sites prior to Site Initiation Visit (SIV)Receives, QC’s, and files site documents in Study Master File
• Provides status of site documents in Study Master File to Clinical Research Associates (CRAs) prior to Monitoring Visits

Clinical Site Management

• CTA is responsible for effective communication with clinical trial sites
• Obtains site documents from Clinical Research Associates during trial
• Addresses inquiries from sites and CRAs
• Escalates issues to study management as needed

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

Establishes and Maintains Tracking of Trial Information

• Team and site contact information
• Site status information
• Equipment and supplies Enrollment trackers
• Adverse event trackers
• Site payment trackers and site payments

How You’ll Get There:

• Bachelor's Degree with background in science, or equivalent work experience preferred
• 2-5 years clinical work experience in the bio- pharmaceutical or device industry, preferably within the ophthalmology field 

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