Clinical Research Manager - NICU Research

University of Iowa•Iowa City, IA

16h•Onsite

About The Position

The UI Stead Family Department of Pediatrics division of Neonatology is seeking to hire a Clinical Research Manager. The Clinical Research Manager 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 and funding agencies; and managing budgets for multiple protocols. About the Stead Family Department of Pediatrics and UI Stead Family Children’s Hospital The Stead Family Department of Pediatrics is a national leader in pediatric medicine. The Department's mission is to provide outstanding care to the children of Iowa and beyond by being a leader in state-of-the-art clinical care to children, performing cutting-edge research to find new treatments and cures for childhood illnesses, and educating the next generation of pediatric health care providers. The Department comprises the medical and research staff of UI Stead Family Children’s Hospital. UI Stead Family Children’s Hospital is one of the nation’s top-ranked pediatric care and research institutions, and Iowa’s only comprehensive children’s hospital. About The Division of Neonatology The nationally recognized Division of Neonatology is committed to providing innovative, comprehensive, high-quality care from our team that results in the best outcomes for infants cared for in the Neonatal Intensive Care Unit (NICU) at the University of Iowa Stead Family Children’s Hospital. Each year, approximately 950 babies receive a range of neonatal services in the 88-bed NICU, Iowa’s only Level IV NICU that has been consistently ranked among the top NICUs in the country for over 10 years. The program is home to world leading programs in both neonatal hemodynamics and extreme prematurity. The scope and expertise of divisional neonatologists and pediatric colleagues is such that they are resourced to provide a level of care and services unavailable in most NICUs, including subspecialty neonatal hemodynamics, neurocritical care and extreme prematurity programs, Extracorporeal Membrane Oxygenation (ECMO), hemodialysis, and peritoneal dialysis.

Requirements

A Master’s degree in related field or an equivalent combination of education and experience
3-5 years of experience in health care clinical research
Professional job-related experience fostering or promoting a welcoming and respectful work/academic environment where people feel safe and appreciated; or demonstrated the ability to do so
Excellent interpersonal, written, and verbal communication skills
Excellent organizational skills
Ability to travel out-of-state, less than 10%25

Nice To Haves

Knowledge of regulatory guidelines and procedures
Previous experience in neonatology
Previous experience in IRB, FDA regulations and budget development
Previous supervisory experience
Previous experience with Redcap and proficiency with Excel

Responsibilities

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 a general 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
Assists with the creation and maintenance of 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