staff to develop study documentation, maintain regulatory records, and monitor study progress, timelines, and deliverables. Responsibilities include coordinating study activities, overseeing data quality and reporting requirements, and ensuring adherence to institutional, federal, and sponsor guidelines.
Department Summary
The Department of Pediatrics is the second largest department in the University of Utah School of Medicine and one of the largest pediatric departments in the country. We are committed to improving the lives of children through excellence in advocacy, education, research, and clinical care. For more information about the Department of Pediatrics, please visit: http://medicine.utah.edu/pediatrics/. Mutual respect and appreciation are highly valued in the department.
Benefits Summary
The University of Utah offers a comprehensive benefits package including:
Additional benefits information is available at https://benefits.utah.edu/.
Responsibilities
Essential Functions: Coordinate all aspects of clinical studies from initiation through delivery. Build and maintain relationships with sponsors, investigators, and research staff. Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports. Maintain required records and ensure compliance with protocols, regulatory regulations, and overall clinical objectives. Record adverse event and side effect data and confer with investigators regarding reporting of events to oversight agencies. Utilize project management methodologies, lead cross-functional teams, resolve issues within the clinical study, and ensure that all targets, timelines, budgets, and requirements are met.
- Coordinate clinical research studies from initiation through completion, ensuring adherence to protocols, timelines, and regulatory requirements.
- Prepare and maintain study-related documentation, including IRB submissions, protocol materials, regulatory binders, and progress reports.
- Collaborate with investigators, sponsors, and research staff to support study startup, execution, and closeout activities.
- Ensure compliance with institutional, federal, and sponsor guidelines, including maintaining accurate and complete study records.
- Monitor study progress, resolve operational issues, and communicate updates to appropriate stakeholders.
- Track, document, and support reporting of adverse events, protocol deviations, and safety information in accordance with regulatory requirements.
