Clinical Research Coordinator – Ketamine Trial Specialist

Utah; Salt Lake City (UT); Vor Ort; USD 51.000 - 63.000; Vollzeit

Zusammenfassung

University of Utah in Salt Lake City seeks a Clinical Research Coordinator III (Non-R.N.) to support a NIDA-funded ketamine-assisted psychotherapy trial for opioid use disorder. You will coordinate daily trial activities, manage data, ensure compliance, and liaise with investigators and sponsors.

Responsibilities include recruitment, consent, site coordination, adverse event reporting, and maintaining source documents. Preference for experience with vulnerable populations and GCP adherence.

Qualifikationen

• Requires a bachelor’s (or equivalency) + 6 years or a master’s (or equivalency) + 4 years of directly related work experience.

Aufgaben

• 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, escalation of 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.

Ausbildung

Bachelor's degree or higher in a related field

Jobbeschreibung

University of Utah in Salt Lake City seeks a Clinical Research Coordinator III (Non-R.N.) to support a NIDA-funded ketamine-assisted psychotherapy trial for opioid use disorder. You will coordinate daily trial activities, manage data, ensure compliance, and liaise with investigators and sponsors.

Responsibilities include recruitment, consent, site coordination, adverse event reporting, and maintaining source documents. Preference for experience with vulnerable populations and GCP adherence.