Clinical Research Coordinator III

This clinical research coordinator position will involve assisting with a NIDA-funded UG3/UH3 trial of ketamine-assisted psychotherapy for patients with opioid use disorder on buprenorphine. The study compares an 8-week Mindfulness-Oriented Recovery Enhancement (MORE) + 2 ketamine sessions to an 8-week supportive therapy intervention + 2 ketamine sessions. In addition to clinical outcomes and experiential outcomes, the trial examines dyadic EEG synchrony between study participants and the study therapist to better understand how therapeutic alliance, connection, and engagement predict therapeutic outcomes in psychedelic-assisted therapies.

Responsibilities

• Coordinate and manage day-to-day clinical trial operations in compliance with Good Clinical Practice guidelines, study protocols, institutional policies, and applicable local, state, and federal regulations.
• Independently plan, organize, and implement complex study activities to meet protocol objectives, including scheduling and conducting study visits, procedures, and required follow-up.
• Serve as an operational liaison along with another full-time coordinator for assigned studies, collaborating effectively with Principal Investigators, study sponsors, clinical teams, ancillary departments, external partners, and regulatory entities.
• Lead participant recruitment, screening, enrollment, and informed consent processes, ensuring ethical conduct, protocol adherence, and subject safety.
• Collect, review, and maintain accurate and complete source documentation, regulatory binders, and study records, ensuring audit and inspection readiness at all times.
• Coordinate and support pre-study feasibility, site qualification, study initiation, monitoring, and close-out visits, including preparation of materials and timely resolution of action items.
• Identify, document, and report adverse events, serious adverse events, and protocol deviations in accordance with regulatory requirements and sponsor timelines.
• Oversee collection, entry, and quality control of participant, clinical, and laboratory data, resolving queries and discrepancies with minimal oversight.
• Develop, maintain, and utilize tracking tools to monitor study milestones, enrollment progress, regulatory deadlines, and other key performance metrics, providing regular updates to investigators and management.
• Apply advanced knowledge and independent judgment to troubleshoot complex study issues, escalate risks appropriately, and recommend process improvements.
• Provide guidance, training, or informal mentorship to junior research staff, contributing to team effectiveness and consistent application of best practices.
• Maintain participant-focused communication, working directly with research participants and families to support engagement, education, and retention throughout the study lifecycle.

Requirements

• Bachelor’s degree (or equivalency) plus 6 years of directly related work experience, or a master’s degree (or equivalency) plus 4 years of directly related work experience.
• Highly skilled and proficient in clinical research coordination with the ability to conduct complex, important work under minimal supervision.
• Preference given for prior experience working with individuals with substance use disorders or vulnerable populations.

Benefits

Learn more about the benefits of working for University of Utah: benefits.utah.edu.

Pay

$57,000

Full-time position located on campus. Requisition Number: PRN45869B