Clinical Research Supervisor

About the Role

The Divisions of Critical Care and Clinical Pharmacology are seeking a Clinical Research Supervisor to manage clinical research operations for both divisions. This role involves research coordination, regulatory initiation and maintenance, ensuring compliance, and building relationships with stakeholders.

Key Responsibilities

• Direct and supervise clinical research operations, including research coordination, monitoring, interviewing, and patient services.
• Develop research studies, create standards and guidelines for clinical research services and programs, and monitor adherence to protocols.
• Ensure clinical research strategies, policies, and procedures are maintained.
• Ensure adherence to Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and all applicable regulations.
• Prepare reports and inform upper-level management of progress and problems.
• Prepare, submit, and maintain IRB, FDA, NIH, and all other regulatory processes.
• Oversee compliance with study protocols, manage quality control, and ensure completion and submission of study-related documentation.
• Recognize, track, and report adverse events and protocol deviations.
• Monitor enrollment goals and initiate strategies to promote enrollment and participant compliance.
• Coordinate responsibilities related to research participants, including determining subject availability, developing informed consents, screening and recruiting subjects, obtaining informed consent, answering subject inquiries, overseeing study visits, processing study samples, and liaising between participants and study parties.
• Provide study-specific education and training for faculty, fellows, Primary Children’s Hospital staff, and students.
• Assist in assessing, planning, designing, budgeting, and initiating future studies.
• Collaborate with study sponsors and PIs to establish study objectives, procedures, and deadlines.
• Oversee day-to-day research activities to ensure progress towards study objectives and deadlines.
• Supervise other members of the research team, including monitoring time tracking, FTE allocation, and conducting performance evaluations.
• Provide training and professional development opportunities for the team.
• Collaborate with the division administrator to monitor study expenditures, order supplies, assist with budget/funding updates, and analyze fund expenditures.
• Coordinate and prepare reports for internal and external customers.
• Participate in on-call rotation for research coordinator tasks as needed.

Requirements & Tech Stack

• Bachelor's degree (or equivalency) in a related field with up to 2 years of directly related work experience, OR a Master's degree (or equivalency).
• Working knowledge of team function within the organization.
• This is a Supervisor-Level position in the Management track.

Qualifications

• Experience with the University of Utah research infrastructure (OnCore, ERICA, eReg, REDCap, etc.) is preferred.
• CITI Training, Good Clinical Practices (GCP), HIPAA are preferred.
• 2+ years of research regulatory management including IRB submission and maintenance experience is preferred.
• 3+ years of clinical research coordinator experience including screening, consenting, enrolling, processing samples, and data entry is preferred.
• Demonstrated ability to manage multiple studies at a time is preferred.
• Knowledge of medical terminology is preferred.
• 1+ year of experience managing other team members is preferred.
• This position is patient-sensitive and requires fulfillment of associated vaccination requirements or approved exemption.