Neonatal Research Operations Manager

University of Utah; Salt Lake City (UT); On-site; USD 90,000 - 125,000; Full time

Benefits offered by this job

Healthcare coverage

/Tuition reduction

Paid leave

Job summary

University of Utah is seeking a Research Nurse Manager in the Department of Pediatrics to provide operational and clinical leadership for neonatal research activities conducted in the NICU and Developmental Assessment Clinic. The role oversees research nursing, regulatory, and data management staff, manages study startup through closeout, and ensures compliance with SOPs, GCPs, and applicable regulations.

The position offers multiple levels with pay determined by department and budget

Qualifications

• Utah Licensed Registered Nurse with a minimum of 2 years providing direct care in pediatrics, mother-baby, or neonatal intensive care.
• A minimum of 4 years in clinical research.

Responsibilities

• Direct/Manage/Supervise the organization’s clinical research operations including research coordination, monitoring, interviewing, and patient services.
• Develop research studies and create standards and guidelines for clinical research services and programs, monitoring adherence to protocols.
• Ensure clinical research strategies, policies, and procedures are maintained.
• Ensure adherence to SOPs, GCPs, and all applicable regulations.
• Prepare reports and keep upper-level management informed of progress and problems.
• Lead and Manage Neonatal Clinical Research Operations.
• Provide direct leadership, supervision, coaching, and performance management for a team of research nurses, regulatory personnel, and data management staff.
• Monitor team workload, staffing resources, and study assignments to ensure appropriate coverage for active and anticipated research projects.
• Serve as a clinical and operational resource for research staff and investigators, providing guidance regarding study implementation and protocol requirements.
• Maintain research coverage by performing clinical research activities as needed within the NICU and affiliated clinical programs.
• Participate in rotational weekend coverage, as required by study protocols or operational needs.
• Lead and facilitate research-related meetings with investigators, collaborators, sponsors, and divisional leadership to support program objectives and operational effectiveness.
• Direct Industry-Sponsored Clinical Trial Activities
• Provide oversight of all administrative, clinical, and operational activities associated with industry-sponsored clinical trials from study feasibility through closeout.
• Serve as the primary operational contact for study sponsors, CROs, and collaborating institutions.
• Collaborate with investigators, research administration, and finance personnel to evaluate study feasibility, negotiate budgets, and allocate resources.
• Facilitate study startup activities, including protocol review, operational planning, regulatory submissions, and study-specific training.
• Ensure study procedures are integrated into routine clinical workflows within the NICU and associated clinical settings.
• Oversee study conduct to ensure compliance with protocol requirements, sponsor expectations, institutional policies, and regulatory standards.
• Monitor enrollment, protocol adherence, study timelines, and data quality throughout the study lifecycle.
• Prepare and distribute study metrics, operational reports, and research updates to investigators and leadership.
• Coordinate study closeout activities and ensure completion of all required documentation and regulatory obligations.
• Oversee Investigator-Initiated Research Studies
• Provide operational and regulatory leadership for investigator-initiated studies to support development of neonatal research.
• Collaborate with principal investigators in protocol development, study design, and operational planning.
• Assist in the preparation and maintenance of research documents, study manuals, regulatory submissions, and study-specific procedures.
• Coordinate required institutional and regulatory reviews, including IRB submissions, amendments, and continuing reviews.
• Provide guidance regarding study implementation, participant recruitment strategies, and protocol execution.
• Support grant submissions through development of research budgets, operational plans, and study resource projections.
• Monitor study progress and identify opportunities to improve compliance, efficiency, and participant enrollment.

Job description

University of Utah is seeking a Research Nurse Manager in the Department of Pediatrics to provide operational and clinical leadership for neonatal research activities conducted in the NICU and Developmental Assessment Clinic. The role oversees research nursing, regulatory, and data management staff, manages study startup through closeout, and ensures compliance with SOPs, GCPs, and applicable regulations.

The position offers multiple levels with pay determined by department and budget