Clinical Trial Associate II

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Requirements:

• Bachelor's degree with a minimum of 1-year experience in clinical trials associate; experience may be considered in lieu of degree.
• Ophthalmic experience is strongly preferred.
• Ability to work in a semi-virtual, cross-functional team environment.
• Knowledge of GCP/ICH regulations and experience maintaining electronic trial master files.
• Excellent verbal and written communication skills.
• Exceptional organizational and time management skills.

Responsibilities:

• Ensure study documentation, communication, training and data collection aligns with study protocol and regulations.
• Lead the development of assigned study-related documents (e.g., informed consent, source documents).
• Participate in all phases of clinical trial site management.
• Collect and review site regulatory documents for accuracy.
• Prepare essential document packages for study approvals.
• Create regulatory packages for IRB/IEC submissions.
• Maintain the Trial Master File and support project management activities.
• Assist with audit preparations and process improvements.