Clinical Research Associate II
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Job Description
Clinical Research Associate managing site activities for clinical trials at Lexitas, focusing on ophthalmology. Overseeing compliance and data integrity while providing guidance to site personnel.
Responsibilities:
- Oversee and review site activities for clinical trials
- Monitor trial records for subject protection and data verifiability
- Perform pre-study, initiation, interim monitoring and close out visits
- Manage all aspects of a clinical study
- Provide technical, scientific, and operational guidance to site personnel
- Track and report enrollment and identify issues
- Coordinate the collection and approval of essential and regulatory documents
- Assist team members with site-specific issues and mentor junior CRAs
Requirements:
- B.S./B.A. in a health related or scientific field
- Minimum of 3 years of experience in clinical research
- Experience in field monitoring as a Clinical Research Associate for a minimum of 3 years
- At least 1 year of ophthalmology monitoring experience
- Knowledgeable about GCP and FDA regulations
- Strong preference for CRAs who have COA or COT certifications (or refraction experience)
- Ability to travel 60% to 70% of time
- Applicants must be based on the East Coast
Benefits:
- None provided
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