Clinical Research Coordinator II – Full‑time

About the role

The Department of the Clinical Translational Research Site seeks a full‑time Clinical Research Coordinator II to support moderate‑risk clinical studies at the Don Soffer Clinical Research Center. The coordinator will manage study activities from initiation through close‑out, ensuring participant safety and regulatory compliance.

Key responsibilities

• Assist with participant recruitment, screening, and retention.
• Perform study procedures, collect data, and manage daily operations of moderate‑risk protocols.
• Collect, process, pack, and ship specimens according to protocol and regulations.
• Maintain study binders, files, and regulatory documentation.
• Distribute study drug materials under PI delegation.
• Monitor and report adverse events, protocol deviations, and unanticipated events.
• Support protocol amendments, orientation, and in‑service training.
• Communicate study progress to investigators and submit required progress reports.

Required profile

• Bachelor’s degree in a relevant field.
• Minimum 2 years of relevant clinical research experience.
• Strong attention to detail, ability to prioritize under pressure, and discretion with confidential information.
• Willingness to work evenings, nights, and weekends as needed.
• Commitment to university core values and ability to work independently or collaboratively.

Required skills

• Knowledge of ICH GCP, IRB, FDA, HIPAA, and safety reporting requirements.
• Proficiency with source documentation, ALCOA+ principles, and electronic data capture (EDC/CRF) systems.
• Experience in query resolution, regulatory file maintenance, and specimen handling.
• Current CITI certification for GCP and Human Subjects.