This job was posted by https://illinoisjoblink.illinois.gov : For moreinformation, please see:https://illinoisjoblink.illinois.gov/jobs/11601311 Department

　　BSD PED - Clinical Trials Office

　　About the Department

　　The Department of Pediatrics at the University of Chicago is a dynamicand stimulating place to work. We strive for the highest level ofcomplex care for children from diagnosis and treatment; provideoutstanding education and training for students, postgraduate scholars,and physicians; and nurture the research of Department scholars who seekto elucidate the causes of pediatric disease and identify promising newtherapies. In addition to our provision of clinical care at UChicagoMedicine (UCM) Comer Children\'s Hospital and at our regional sites, weare currently expanding our clinical care across Northern Illinois andNorthwestern Indiana. In collaboration with our partners in theChicagoland Children\'s Health Alliance (CCHA; Advocate Children\'sHospital, and NorthShore University Health System). CCHA hasresponsibility for the care of almost 1 million children. The Departmenthas 6 ambulatory sites and 3 inpatient sites of care across the regionwith the goal of providing care \'close to home\' whenever feasible(https://pediatrics.uchicago.edu/). Our mission is to improve the healthof every child entrusted to us, in an inclusive environment that iscommitted to family-centered care, clinical excellence, impactfulscholarship, effective disease prevention, and advocacy for theappropriate care of every child. We are especially committed to thechildren on the South Side of Chicago and to altering the inequities inhealthcare. The Department of Pediatrics has approximately 185physicians, physician-scientists, and scientists in 15 sections thatcover the range of pediatric care. Our education program serves thestudents of the College, the Pritzker School of Medicine (PSOM), 70categorical pediatric residents, 6 child neurology residents, 58fellows, and numerous graduate students and post-doctoral fellows. TheDepartment has a staff of 220 advanced practice providers,administrators, research administrators, clinical research associates,and laboratory staff. The Department has an expanding portfolio ofFederal, foundational, and Philanthropic awards, and is committed todoubling its research base in the next three years. The PediatricClinical Trials Office (Peds CTO) is an existing centralized supportoffice that provides services and high level guidance to individuals(faculty, investigators, research staff, and clinic coordinators fromthe University and Hospital) involved in human subjects research. ThePeds CTO is responsible for establishing standards, operatingprocedures, policies and practices, implementing educational andtraining programs, developing communication tools, and managing theadministrative functions that impact individuals involved in clinicalresearch.

　　Job Summary

　　The Pediatric Clinical Research Coordinator 2 provides support to theSection of Pediatric Gastroenterology. The CRC 2 will be involved incoordinating all aspects of studies under the supervision of a PI. TheClinical Research Coordinator 2 works under the direction of Dr. RituVerma and Dr. Ranjana Gokhale and the leadership within the PediatricClinical Trials Office. Clinical trial tasks may include study conceptdevelopment, protocol development and writing, study administration anddata collection for an investigator-initiated trial and other newresearch projects developed by the PIs.

　　Responsibilities

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

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

　　Collect, process, ship and store specimens to appropriate l boratoryaccording to established aseptic techniques.

　　Identify and explain the responsibilities of Principal Investigators,research team members, sponsors, contract research organizations (CROs),and regulatory authorities related to the conduct of a clinical trial.

　　Coordinate the conduct of the study from startup through closeoutincluding recruitment and screening of study subjects, obtaininginformed consent, collecting research data, and ensuring protocoladherence.

　　Plan and coordinates patient schedule for study procedures, returnvisits, and study treatment schedules.

　　Educate patients about study procedures to be performed, visit schedule,what to report between and during visits, and the risks and benefits ofthe procedures.

　　Perform assessments at visits and monitors for adverse events.

　　Organize and attend site visits from sponsors and other relevant studymeetings.

　　Protect patients and data confidentiality by ensuring security ofresearch data and personal health information and compliance withfederal regulations and sponsor protocols.

　　Ensure Standard Operating Procedures (SOP) are implemented anddocumented in accordance to study sponsor, primary investigator, andregulatory agency specifications.

　　Maintain accurate and complete records which may includ