This job was posted by https://illinoisjoblink.illinois.gov : For moreinformation, please see:https://illinoisjoblink.illinois.gov/jobs/11611403 Department

　　BSD PED - Clinical Trials Office

　　About the Department

　　In the Department of Pediatrics at the University of Chicago, we striveto provide the highest level of complex care for children from diagnosisand treatment to conducting research to find promising new therapieswith a focus on teaching. We are committed to advancing the frontiers ofknowledge, and the education and training of future clinicalpediatricians, subspecialists, educators, clinical investigators andphysician-scientists. The Department of Pediatrics is a dynamic,stimulating place to work, and because we are focused on growth andimproved excellence, our staff have particularly challenging andrewarding roles.

　　The Pediatric Clinical Trials Office (Peds CTO) is an existingcentralized support office that provides services and high levelguidance to individuals (faculty, investigators, research staff, andclinic coordinators from the University and Hospital) involved in humansubjects research. The Peds CTO is responsible for establishingstandards, operating procedures, policies and practices, implementingeducational and training programs, developing communication tools, andmanaging the administrative functions that impact individuals involvedin clinical research.

　　Job Summary

　　The Senior Pediatric Clinical Research Coordinator support to thesection of Pediatric Gastroenterology, within the Biological SciencesDivision. The Sr CRC will be involved in multiple research trial types:investigator initiated, multi-centered cooperative group studies, andmulti-centered trials designed, implemented and coordinated in theSection. The Senior Clinical Research Coordinator is a specializedresearcher partnering with the Principal Investigator (PI) and under thedirection of a departmental research director. While the PrincipalInvestigator is primarily responsible for the overall design, conduct,and management of the clinical trial, the Sr CRC supports, facilitatesand coordinates independently the daily clinical research activities andplays a critical role in the conduct of the study. The Sr CRC alsooversees other clinical research coordinators and student workers withinthe Pediatric Clinical Trials Office and the Section. By performingthese duties with limited supervision and/or guidance, the Sr CRC workswith the PI, department, sponsor, and institution to support and provideguidance on the administration of the compliance, financial, personneland other related aspects of the clinical study.

　　Our department follows a hybrid work structure that fostersproductivity, collaboration, and employee well-being. Working from theoffice is encouraged for tasks that require a high degree ofcollaboration. iversity.

　　Responsibilities

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

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

　　Serve as a resource person or act as a consultant within area ofclinical expertise.

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

　　Maintain working knowledge of current protocols, and internal SOPs.

　　Be accountable for high standards of clinical research practice andassist in the development of accountability in others.

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

　　Oversee and participate in the coordination and conduct of complexclinical research studies and ensure compliance with federal andinstitutional regulations.

　　Prepare, submit, and assist Investigators ith multiple levels ofresearch 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, approvetime off, etc.), or assist.

　　Attend continuing education and training opportunities relevant to jobduties.

　　Analyzes, facilitates and participates in the daily activities ofmultiple moderately complex clinical trials and performs all aspects ofclinical data management, including patient data retrieval, referring MDoffice records, preparing clinical research charts, and participation inprogram audits.

　　Prepares program conference lists for multidisciplinary conferences andworkshops. Participates in all pharmaceutical site visits. Uses moderateunderstanding of clinical trials to collect and store patient specimens,radiology scans and reports.

　　Solves a range of straightfor