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BSD PED - Clinical Trials Office

About the Department

The Department of Pediatrics at the University of Chicago is a dynamic and stimulating place to work. We strive for the highest level of complex care for children from diagnosis and treatment; provide outstanding education and training for students, postgraduate scholars, and physicians; and nurture the research of Department scholars who seek to elucidate the causes of pediatric disease and identify promising new therapies. In addition to our provision of clinical care at UChicago Medicine (UCM) Comer Children\'s Hospital and at our regional sites, we are currently expanding our clinical care across Northern Illinois and Northwestern Indiana. In collaboration with our partners in the Chicagoland Children\'s Health Alliance (CCHA; Advocate Children\'s Hospital, and NorthShore University Health System). CCHA has responsibility for the care of almost 1 million children. The

Department has 6 ambulatory sites and 3 inpatient sites of care across the region with the goal of providing care \'close to home\' whenever feasible (https://pediatrics.uchicago.edu/). Our mission is to improve the health of every child entrusted to us, in an inclusive environment that is committed to family-centered care, clinical excellence, impactful scholarship, effective disease prevention, and advocacy for the appropriate care of every child. We are especially committed to the children on the South Side of Chicago and to altering the inequities in healthcare. The Department of Pediatrics has approximately 185 physicians, physician-scientists, and scientists in 15 sections that cover the range of pediatric care. Our education program serves the students of the College, the Pritzker School of Medicine (PSOM), 70 categorical pediatric residents, 6 child neurology residents, 58 fellows, and numerous graduate students and post-doctoral fellows. The Department has a staff of 220 advanced practice providers, administrators, research administrators, clinical research associates, and laboratory staff. The Department has an expanding portfolio of Federal, foundational, and Philanthropic awards, and is committed to doubling its research base in the next three years.

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 Clinical Research Coordinator (CRC) 1 in Pediatrics provides support to the Sickle Cell Disease studies within the Section of Hematology/Oncology within the Department of Pediatrics. The CRC1 will be involved in multiple research trial types: biobanking, registry, observational, multi-institutional pharmaceutical trials, and multi-centered trials designed, implemented and coordinated in the Section. The Clinical Research Coordinator 1 works under the general direction of the Director of Clinical Research and a Senior Clinical Research Coordinator within the Pediatric Clinical Trials Office, as well as the study PI team. The CRC will be attending Sickle Cell Disease clinics including at Comer Children\'s Hospital and LaRabida Children\'s Hospital.

Responsibilities

Aliquot and prepare experimental and clinical samples for freezing.

Ensures accurate storage for all specimen types, including blood and plasma samples.

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

Recruit and interview potential study patients with guidance from PI and other clinical research staff.

Maintains accurate and complete documentation of signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF\'s), and study-related communication.

Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.

Perform experiments, collect, analyze, and interpret data under the supervision of the PI or designee.

Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance with study sponsor, primary investigator, and regulatory agency specifications.

Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and potential side effects.

Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.

Understand the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely prepara