Clinical Research Coordinator – Mid‑Level

About the role

The University of Miami’s Department of Clinical Translational Research seeks a full‑time Clinical Research Coordinator 2 to manage routine‑to‑moderately complex studies in Otolaryngology. This mid‑level position supports protocol implementation, data management, and participant safety.

Key responsibilities

• Perform chart reviews, pre‑screen participants, and maintain enrollment procedures according to study protocols.
• Coordinate study activities including data collection, scheduling visits, managing timelines, and preparing for sponsor monitoring visits.
• Monitor adverse events, report protocol deviations, and ensure compliance with international, national, and local regulatory requirements.
• Maintain regulatory binders, source documentation, and electronic data capture systems while supporting quality‑improvement initiatives.

Required profile

• Bachelor’s degree in a relevant field with a minimum of three years of clinical research experience.
• Demonstrated ability to work independently, prioritize under pressure, and handle confidential information with discretion.
• Commitment to university values, willingness to work evenings, nights, or weekends as needed, and ability to collaborate with investigators and study teams.

Required skills

• Proficiency in data management, source documentation, and ALCOA+ principles.
• Experience with electronic data capture (EDC) systems, case report forms (CRF), and query resolution.
• Knowledge of ICH GCP, IRB/FDA regulations, HIPAA/privacy, and safety reporting requirements.
• Current CITI certification in GCP and Human Subjects.