​​Senior Clinical Research Coordinator​​ 2

Department

BSD PED - Clinical Trials Office: Allergy and Immunology

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 Clinical Research Coordinator 2 will provide support to the Section of Allergy/Immunology and Pediatric Pulmonology. The Sr CRC 2 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 2 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 2 supports, facilitates and coordinates independently the daily clinical research activities and plays a critical role in the conduct of the study. The Sr CRC 2 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 2 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.

This at-will position is wholly funded by extramural funds (e.g., grant, gift, endowment) which are renewed under provisions set by the grantor of the funds. Employment will be contingent upon the continued receipt of these funds and satisfactory job performance.

Responsibilities

• Manages high complexity clinical studies and owns administrative tasks. Assists with strategic planning for the research department. Trains lower-level roles. 
• Studies have high complexity with limited oversight.  
• Manages all aspects of conducting clinical trials including screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports. Acts as a liaison with medical staff, University departments, ancillary departments and/or satellite facilities.  
• Acts as a leader within the department/unit through improving clinical research practice and serving as a resource.  
• Maintains working knowledge of current protocols and internal SOPs.  
• Accountable for high standards of clinical research practice and assists in the development of accountability in others.  
• Develops and implements procedures, maintains records, tracks progress, and conducts quality assurance on data collected.  
• Oversees and participates in the coordination and conduct of complex clinical research studies and ensures compliance with federal and institutional regulations. 
• Prepares, submits, and assists investigators with multiple levels of research documentation, such as IRB submissions, educational materials, reports, grant renewal reports, and study forms.  
• Provides investigators with guidance regarding protocol requirements.  
• Maintains regulatory documentation.  
• Assists other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety