Clinical Research Coordinator 1 – Pediatrics

Department 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 expanded its presence to numerous satellite 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 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 section of Infectious Disease within the Department of Pediatrics. The Clinical Research Coordinator 1 works under the general direction of the Director of Clinical Research, the PI, and the study team. The CRC will be involved in multiple research trial types: multi-centered cooperative group and intergroup studies at a national level, multi-institutional pharmaceutical trials, and multi-centered trials designed, implemented and coordinated in the Section with their primary responsibility coordinating vaccine clinical trials. Responsibilities Aliquot and prepares experimental and clinical samples for freezing. Ensures accurate storage for all specimen types, including blood and plasma samples. Coordinates all aspects of conducting clinical trials including screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports. Recruits and interviews 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. Performs experiments; collects, analyzes, and interprets 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. Protects patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols. Understands the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions independently. Coordinates the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence. Assists with preparation and attends intervention sessions. Protects patients and data confidentiality by ensuring security of research data, personal health information, and compliance with federal regulations and sponsor protocols. Ensures compliance with federal regulations and institutional policies. Prepares for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Participates in study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports. Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules. Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures. Performs assessments at visits and monitors for adverse events. Organizes and attends site visits from sponsors and other relevant study meetings. May prepare and maintain protocol submissions and revisions. May assist in the training of new or backup coordinators. Performs various aspects of clinical research, such as collecting and processing specimens, interviewing subjects, taking vital signs, and contributing to the case report. Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports. Accountable for all tasks in basic clinical studies. Assists with various professional, organizational, and operational tasks under direct supervision. Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples. Performs other related work as needed. Minimum Qualifications Education: Minimum requirements include a college or university degree in related field. Work Experience: Minimum requirements include knowledge and skills developed through