Job Description

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 follow-up 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 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 Cardiology:

The Division of Cardiology at the University of Iowa Stead Family Department of Pediatrics provides compassionate, family-centered, and state-of-the-art 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 multi-purpose diagnostic and interventional procedure lab which is constantly expanding and including state-of-the-art technologies.

Required Qualifications

• Bachelor’s Degree in a medical or related field or an equivalent combination of education and experience.
• One to three years of work experience in clinical trial protocol management
• Excellent written, verbal and interpersonal communication skills.
• Demonstrated experience extracting medical information and data from an electronic medical record system (e.g. Epic).
• Knowledge of Institutional Review Board procedures, FDA regulations, GCP and study sponsor. guidelines related to clinical trial research.
• Experience working independently and in a group setting.
• Experience managing information requiring attention to detail and high level of organization.
  

Desirable Qualifications

• Demonstrated basic knowledge of congenital heart disease, congenital heart surgery, catheterization procedures, arrhythmias, and device therapy.
• Research experience with REDCap, Excel, IRB, multicenter studies, and grant applications.
• Knowledge of University of Iowa policies, procedures, and regulations.
• CCRC (Certified Clinical Research Coordinator) or CCRP (Certified Clinical Research Professional) certification.

Position and Application Details:

In order to be considered for an interview, applicants must upload the following documents and mark them as a “Relevant File” to the submission:

• Resume
• Cover Letter

Job openings are posted for a minimum of 14 calendar days and may be removed from posting and filled any time after the original posting period has ended.

Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification. Up to 5 professional references will be requested at a later step in the recruitment process.

For additional questions, please contact Pediatrics Human Resources at [email protected]

This position is eligible for a combination of on-campus (UIHC) and remote work. Remote work must be performed at an offsite location within the state of Iowa. Per policy, work arrangements will be reviewed annually, and must comply with the remote work program and related policies and employee travel policy when working at a remote location. Work arrangement options will be discussed during the hiring process.

This position is not eligible for university sponsorship for employment authorization.

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