Senior Pediatric Clinical Research Coordinator

Department
 

BSD PED - Clinical Trials Office

About the Department
 

In the Department of Pediatrics at the University of Chicago, we strive to provide the highest level of complex care for children from diagnosis and treatment to conducting research to find promising new therapies with a focus on teaching. We are committed to advancing the frontiers of knowledge, and the education and training of future clinical pediatricians, subspecialists, educators, clinical investigators and physician-scientists. The Department of Pediatrics is a dynamic, stimulating place to work, and because we are focused on growth and improved excellence, our staff have particularly challenging and rewarding roles.

The Pediatric Clinical Trials Office (Peds CTO) is an existing centralized support office that provides services and high level guidance to individuals (faculty, investigators, research staff, and clinic coordinators from the University and Hospital) involved in human subjects research. The Peds CTO is responsible for establishing standards, operating procedures, policies and practices, implementing educational and training programs, developing communication tools, and managing the administrative functions that impact individuals involved in clinical research.

Job Summary
 

The Senior Pediatric Clinical Research Coordinator support to the section of Pediatric Gastroenterology, within the Biological Sciences Division. The Sr CRC will be involved in multiple research trial types: investigator initiated, multi-centered cooperative group studies, and multi-centered trials designed, implemented and coordinated in the Section. The Senior Clinical Research Coordinator is a specialized researcher partnering with the Principal Investigator (PI) and under the direction of a departmental research director. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the Sr CRC supports, facilitates and coordinates independently the daily clinical research activities and plays a critical role in the conduct of the study. The Sr CRC also oversees other clinical research coordinators and student workers within the Pediatric Clinical Trials Office and the Section. By performing these duties with limited supervision and/or guidance, the Sr CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.

Our department follows a hybrid work structure that fosters productivity, collaboration, and employee well-being. Working from the office is encouraged for tasks that require a high degree of collaboration. iversity.

Responsibilities

• Manages all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.  

• Act as a liaison with medical staff, university departments, ancillary departments and/or satellite facilities. 

• Serve as a resource person or act as a consultant within area of clinical expertise. 

• Act as a leader within the department/unit through improving clinical research practice and serving as a resource. 

• Maintain working knowledge of current protocols, and internal SOPs. 

• Be accountable for high standards of clinical research practice and assist in the development of accountability in others. 

• Develop and implement procedures, maintain records, track progress, and conduct quality assurance on data collected. 

• Oversee and participate in the coordination and conduct of complex clinical research studies and ensure compliance with federal and institutional regulations. 

• Prepare, submit, and assist Investigators with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms). 

• Provide Investigators with guidance regarding protocol requirements. 

• Maintain regulatory documentation. 

• Assist other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety Review Committee. 

• Provide direct supervision of other clinical research staff (i.e. hiring/firing, performance evaluations, disciplinary actions, approve time off, etc.), or assist. 

• Attend continuing education and training opportunities relevant to job duties. 

• Analyzes, facilitates and participates in the daily activities of multiple moderately complex clinical trials and performs all aspects of clinical data management, including patient data retrieval, referring MD office records, preparing clinical research charts, and participation in program audits.