Clinical Trials Research Associate - Pediatrics Cardiology

The UI Stead Family Department of Pediatrics, division of Cardiology is seeking a Clinical Trials Research Associate.  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 to include:  

• Manage clinical trials and other research activities in Pediatric Cardiology. 
• Assist in the design, development, execution administration and maintenance of protocols and clinical studies. Assist in study design and protocol development and provide input into descriptions of complex research procedures.
• Collaborate with principal investigators and fellows to design and develop research studies including retrospective chart review projects and prospective studies. Develop a timeline and research protocol prior to IRB submission.
• Oversee case report form development. Assist in the development of data collection instruments and in designing the REDCap databases with input from the principal investigator.
• Review query reports and resolve data queries. Coordinate and resolve all monitoring visit issues.
• Perform and monitor randomizations.
• Develop complex study materials.
• Serve as liaison between local principal investigators, coordinating sites, agencies, and sponsors.
• Perform regulatory activities including submission of applications and protocols to the IRB and other review committees for approval prior to implementing research, as necessary for modifications, and then annually for continuing review approvals. Submit Human Subjects Research Determination (HSRD) forms as necessary.
• Monitor implementation of study per protocol and ensure procedures are conducted using good clinical practice standards and meeting IRB guidelines.
• Responsible for safety programs by following guidelines and maintaining required documentation.  Document all participant Serious Adverse Events and Adverse Events and report these to the primary investigator, study sponsor, and IRB.
• Oversee the recruitment of subjects. Screen, recruit, enroll and obtain informed consent for research studies and clinical trials.
• Educate study participants on purpose and scope of study, potential risks and benefits, possible alternatives, and study requirements for participants.
• Record the enrollment of subjects following consent.
• Identify eligible patients for research studies using SlicerDicer, TriNetX and other software. Track patient upcoming appointments to facilitate the recruitment of subjects for studies.
• Schedule research and trial-related procedures as outlined in the protocol.
• Perform telephone follow-up and monitoring of research subjects as required.
• Document all study data in participant source documents and transfer these data to electronic case report forms.  Ensure study data are valid and reliable. 
• Review data entered by others post entry to ensure data is accurate and of high quality; assist with statistical analysis of data.
• Participate in the design, development and testing of clinical research trial data systems.
• Assist with the development and maintenance of research study budgets. Collaborate with Pediatric Research Finance to ensure proper invoicing.
• Use statistical analysis software (REDCap) to analyze and summarize study data. 
• Collaborate with study sponsors to manage protocols for clinical trials.  Meet with study monitors and resolve monitoring visit issues.
• Coordinate research studies by interacting wit