The Clinical Research Manager within the UI Stead Family department of Pediatrics (Neonatology) is responsible for providing oversight to all clinical research study activities in the UI Stead Family Department of Pediatrics, Division of Neonatology; interfacing with administrative and clinical staff, providing expertise and leadership in conducting multiple scientific protocols simultaneously; providing oversight to Neonatal Research Network research operations at the University of Iowa and Sanford Health in Sioux Falls, South Dakota; supporting research staff in conducting research procedures with NICU patients; co-directing the monthly Iowa Neonatal Clinical Research Committee (iNCRC) meeting; managing research team staff; coordinating the processing and analysis of data; presenting study information to clinical staff, funding agencies and patient families; and managing budgets for multiple protocols.

Duties to include:

• Works closely with the Neonatology Division Director and the Neonatology Research Director to cultivate a progressive strategy for clinical research within the division
• Manages all aspects of the research program in the Division of Neonatology at Stead Family Department of Pediatrics
• Provides oversight to Neonatal Research Network (NRN) research operations in the Division of Neonatology at Stead Family Department of Pediatrics, University of Iowa as well as NRN-related studies at the satellite site in Sanford Health in Sioux Falls, South Dakota.
• Oversees the operation of all neonatal clinical research projects in the Division of Neonatology at Stead Family Department of Pediatrics, including the recruitment, coordination and scheduling of subject participation and procedures as required by protocols in the NICU
• Interfaces with administrative and clinical staff at each site, providing leadership in conducting, organizing, improving, and maintaining the delivery of complex scientific protocols, functioning as an expert on all phases of multiple projects conducted simultaneously in the NICU
• Provides consultative services to the principal investigators and other participating centers regarding feasibility, execution, and administration of protocols
• Acts as co-chair of the Iowa Neonatal Clinical Research Committee
• Maintains knowledge of the care of infants, especially premature infants
• Assists with writing grant applications, writes directions for study procedures, collaborates with healthcare and ancillary services in conduction of studies, assuring that enrollment is accruing as expected, data collection and entry is complete and accurate, and assist with data tabulation and writing for scientific publications and presentation at meetings
• Oversees quality assurance/auditing of individual subject data
• Oversees the monitoring of the health status and safety of all subjects during study participation, including troubleshooting of equipment and pharmacy processes for protocols
• Assists lead coordinator in developing presentations to orient new nursing and medical staff to multiple research protocols
• Oversees research coordinators in conducting meetings and educational sessions with clinical staff for study procedures and equipment
• Works with coordinators in developing presentations and brochures to recruit study participants
• Works with coordinators in Developing/writing IRB applications and other regulatory requirements for research protocols
• Provides guidance for maintaining regulatory requirements for Sioux Falls Sanford Health
• Serves as administrative liaison with regulatory offices
• Completes regulatory submissions and close out processes
• Hires, develops, and manages the performance of clinical healthcare research associates, research assistants and students, assuring that all are compliant with UI policies and procedures
• Manages all research personnel (research assistants, associates and data abstractors) which includes regular one-on-one meetings
• Attends daily research team huddle
• Creates and maintains NICU clinical research team schedule, including on-call
• Maintains records of ethical, regulatory, and good clinical practices training among all research staff at Stead Family Department of Pediatrics, division of neonatology
• Performs public relations activities on behalf of the division of neonatology and Sanford Health
• Provides leadership and management of budgets for clinical research protocols in the neonatology division; meets regularly with division administrative personnel and departmental financial research support manager; continuously monitors and approves expenditures for studies to keep within budgetary constraints for protocols
• Oversees the operations of the division of neonatology national and internal databases/registries, ensuring accurate and timely data acquisition and entry, auditing and reviewing records, coordinating with division members in obtaining data and reports