Clinical Trials Research Assistant - Pediatrics Cardiology

Within the Division of Cardiology in the Stead Family Department of Pediatrics this position provides support for clinical trials and research projects by conducting study visits collecting and analyzing results and performing operational duties associated with human research. This is a specified term position.

Duties include:

• Manage clinical research and trials in Pediatric Cardiology.
• Prepare and submit IRB applications and other committee reviews prior to implementing research.
• Prepare and submit IRB modifications and continuing reviews.
• Maintain regulatory documentation.
• Monitor implementation of study per protocol and ensure procedures are conducted using good clinical practice standards and meeting IRB guidelines.
• Oversee safety programs by following guidelines and maintaining required documentation.
• Document and report adverse events (AEs) to the primary investigator study sponsor and IRB.
• Recruit screen and consent patients for enrollment in research studies.
• Perform telephone followup and monitor research subjects as required.
• Help develop a data management plan and design data collection forms.
• Document study data in participant source documents and enter data into electronic case report forms. Ensure study data are valid and reliable by verifying data identifying problem data generating queries etc.
• Review data entered by others to ensure data quality. Participate in data validation query resolution and data audits.
• Use statistical analysis software (REDCap GraphPad PRISM) to analyze and summarize study data.
• Collaborate with study sponsors to manage protocols. Meet with study monitors as requested.
• Assist in writing grant proposals abstracts data reports presentations and manuscripts for publication; create and present posters at local and/or national conferences.
• Triage research related questions from faculty and departmental staff; direct faculty/staff to appropriate resources.
• Coordinate manage and test equipment. Troubleshoot and resolve equipment failures error codes and repairs.
• Help manage student research staff to assure task completion and compliance with UI policies and procedures. Mentor new students under direction.

About the Department of Pediatrics:

The Stead Family Department of Pediatrics is a national leader in pediatric medicine. The Departments mission is to provide outstanding care to the children of Iowa and beyond by being a leader in stateoftheart clinical care to children performing cuttingedge 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 Childrens Hospital. UI Stead Family Childrens Hospital is one of the nations topranked pediatric care and research institutions and Iowas only comprehensive childrens hospital.

About the Division of Cardiology:

The Division of Cardiology at the University of Iowa Stead Family Department of Pediatrics provides compassionate familycentered and stateoftheart delivery of care to children and young adults with congenital and acquired heart disease. Patients are followed through the transition to adulthood. Dedicated staff have expertise in acquired heart diseases such as cardiomyopathies cardiac arrhythmias congenital heart disease cardiac dysfunction in malignancy and cardiac implications associated with pediatric obesity. The division provides the only expertise for electrophysiology diagnostic advanced imaging interventional and transplant services for children and youth in the state of Iowa. Skilled surgical support and exceptional critical care postoperative support has outcomes that have excellent results in national databases. The division has a multipurpose diagnostic and interventional procedure lab which is constantly expanding and including stateoftheart technologies.