Clinical Research Coordinator IV

Overview

The Department of Psychiatry within the Huntsman Mental Health Institute is seeking a Clinical Research Coordinator IV in a full-time role to support a trial looking at ketamine augmentation of Mindfulness Oriented Recovery Enhancement, with potential involvement in other psychedelic-assisted therapy clinical trials. The position involves coordinating day-to-day clinical trial activities in adherence to Good Clinical Practices (GCPs), study protocols, and applicable regulations;

working with the IRB and, ideally, experience with IND related reporting. Responsibilities include implementing processes and organizing efforts within the study team to achieve objectives, coordinating research procedures, study visits, and follow-up care. You will create and maintain tools and documentation to track study metrics and provide updates to management. The role includes conducting pre-study, site qualification, study initiation, monitoring, and close-out activities, maintaining source documents and reporting adverse events.

You will recruit, screen, enroll, and obtain consent from study participants, collect and maintain patient and laboratory data, and work directly with study participants and families while coordinating with other departments, outside organizations, and government agencies. You will work under the direction of the Primary Investigator (PI) and be recognized as a subject matter expert and advanced individual contributor, performing highly specialized work with substantial independent judgment.

• Clinical Trial Coordination – Coordinate day-to-day activities for a clinical research trial focused on ketamine augmentation of Mindfulness Oriented Recovery Enhancement, with opportunities to support additional psychedelic-assisted therapy studies.
• Ensure all study activities follow Good Clinical Practices, approved protocols, and all applicable federal, state, and institutional regulations.
• Organize workflow and implement processes that support efficient study operations and achievement of key milestones.
• Serve as the primary point of contact for participants, families, study team members, partnering departments, external organizations, and government agencies.

• Prepare, submit, and maintain documentation required for Institutional Review Board approval and continuing reviews.
• Conduct and support pre-study visits, site qualification visits, study initiation visits, monitoring visits, and close-out activities.
• Maintain accurate source documents, ensure data integrity, and report adverse events in accordance with regulatory requirements.

• Recruit, screen, and enroll study participants while ensuring an inclusive and ethical recruitment process.
• Obtain informed consent and explain study procedures in a clear and supportive manner.
• Coordinate study visits, research procedures, and follow-up care with attention to participant safety and wellbeing.
• Collect, enter, and maintain participant data, laboratory data, and all other required study information.

• Create and maintain tools, trackers, and documentation that support accurate study metrics and reporting.
• Provide timely updates to the Primary Investigator and study leadership regarding enrollment, progress, and any operational issues.
• Ensure secure and organized management of study records for audit readiness.

• Function as a subject matter expert for complex clinical research activities and provide guidance to team members as needed.
• Exercise independent judgment and autonomy in decision making related to study conduct while working under the direction of the Primary Investigator.
• Contribute to a positive, collaborative, and mission-aligned research environment.

Minimum Qualifications

• Equivalency Statement: 1 year of higher education can be substituted for 1 year of directly related work experience (example: bachelor’s degree = 4 years of directly related work experience).
• Clinical Research Coordinator IV:
  Requires a bachelor's (or equivalency) + 8 years or a master's (or equivalency) + 6 years of directly related work experience.