Job Description

Overview

The Clinical Research Coordinator is responsible for managing and coordinating research patient visits in compliance with ICH-GCP guidelines, IRB-approved protocols, and study manuals. This role involves facilitating day-to-day trial activities, ensuring data accuracy, and supporting study compliance.

Key Responsibilities

• Coordinate and oversee daily clinical trial activities, including patient visits and recruitment to meet enrollment goals.
• Review and comprehend study protocols, timelines, and inclusion/exclusion criteria.
• Conduct informed consent discussions, ensuring proper implementation and documentation.
• Administer sponsor-required questionnaires and collect/update medical histories, adverse events (AEs), and serious adverse events (SAEs).
• Collect, manage, and enter study data into the electronic data capture (EDC) system, resolving queries promptly.
• Maintain and organize regulatory documents, including protocols, investigator brochures, IRB documents, and training records.
• Ensure proper training and documentation for study staff on protocol and related procedures.
• Monitor and maintain study supply inventory (e.g., lab kits, shippers).
• Coordinate and prepare for monitor site visits and address required corrections.
• Attend sponsor meetings, teleconferences, and investigator meetings as required.

Qualifications

Requirements:

• Bachelor's/Associate's degree or equivalent experience
• 3+ years of experience in Clinical Research
• Ophthalmology experience (preferred)

Details:

Location: Orlando, FL

Pay: $60k-$75k (Dependent on background and years of experience)

Hours: Monday - Friday; Normal Business Hours; Onsite 5 Days a Week

Duration: Direct Hire

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