What are the responsibilities and job description for the Clinical Trials Research Associate - Pediatrics Cardiology position at The University of Iowa?
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 with clinic/hospital staff at sites in which studies are being conducted.
- 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. May communicate with IRB staff and investigators.
- Coordinate, manage and test equipment. Troubleshoot and resolve equipment failures, error codes and repairs.
- Hire, train, and manage student research staff to assure task completion and compliance with UI policies and procedures. Provide training in EPIC, REDCap, HawkIRB and the importance of good data collection. Provide direction, assignments, feedback, coaching and counseling to assure outcomes are achieved.
- Administer and/or monitor budgets for studies. Work with Pediatric Clinical Trials and Pediatric Grant Finance staff to develop and monitor project budgets.
- Track patient visits on patient visit logs and answer questions as necessary.
- Regularly attend meetings with the research finance teams to develop study budgets and ensure appropriate invoicing.
- Attend quarterly finance meetings to review research financials for the division.
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.
Desired 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 pedsuichildrenshr@uiowa.edu
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.
