Clinical Research Coordinator II, Department of Medicine

The Pulmonary, Allergy, Critical Care, and Sleep Medicine Division in the Department of Medicine is seeking a Clinical Research Coordinator II to support complex research studies by independently coordinating participant visits, performing intermediate-level clinical and operational tasks, assisting with data management and regulatory documentation, assisting with higher-level study procedures, and assisting with regulatory submissions. This position may be eligible for a flexible schedule work arrangement, subject to discussion with the supervisor.

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Participant Coordination, Visit Execution, and Basic Clinical Support:

• Recruit, screen, consent, and schedule participants with limited supervision.
• Create workflows for clinical assessments, ensuring seamless coordination across study teams.
• Provide participant education on study requirements and treatment-specific procedures.
• Coordinate referral-based procedures and troubleshoot scheduling barriers.
• Perform intermediate clinical support tasks, including specimen collection/processing, vitals, AE assessment and documentation, and escalation of concerns to senior staff.
• Maintain consistent engagement with participants through proactive communication strategies to support retention and adherence.
• Manage complex scheduling demands across multiple studies, including tracking deviations, missed visits, and corrective actions.

Survey Distribution, Data Collection, and Data Entry:

• Oversee timely distribution of scheduled surveys and ensure escalation protocols are followed for non-responders.
• Enter, monitor, and verify data in electronic databases, perform routine data audits.
• Conduct data quality checks, resolve discrepancies, and assist in refining data workflows.
• Support data extraction for internal reports and assist with preparation of summaries or graphs as directed.
• Ensure accurate specimen documentation, chain-of-custody tracking, and compliance with lab handling requirements.

Operational, Regulatory, and Administrative Study Support:

• Prepare, organize, and maintain detailed study documentation, including visit logs, regulatory binders, supply inventories, and site communications.
• Assist in preparation and submission of protocol amendments, consent forms, recruitment materials, and routine IRB documents under supervisor guidance.
• Contribute to SOP development, workflow refinement, and compliance tracking; lead minor updates as needed.
• Provide training and mentorship to Clinical Research Coordinator I staff, student workers, and new team members.
• Participate in team meetings, site coordination discussions, and quality-assurance activities, occasionally leading activities.
• Support study program administration, including reporting, coordination with pharmacy, and site-level logistics.

Knowledge, Skills & Abilities:

• Demonstrated excellent phlebotomy skills.
• Knowledge of ethics and regulations for human subjects' research.
• Strong interpersonal skills and excellent communication.
• Knowledge of medical terminology and conditions.
• Advanced organizational skills with exceptional attention to detail.

This job posting reflects the general nature and level of work expected of the selected candidate(s). It is not intended to be an exhaustive list of all duties and responsibilities. The institution reserves the right to amend or update this description as organizational priorities and institutional needs evolve.

• Bachelor's degree or equivalent advanced learning attained through professional level experience required.
• Three (3) years of relevant work experience, or equivalent combination of education and work experience.