Clinical Research Coordinator 1 - Pediatrics
Department BSD PED - Clinical Trials Office - Research Support 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 Clinical Research Coordinator (CRC) 1 in Pediatrics provides support to the Section of Pediatric Gastroenterology. The CRC 1 will be involved in coordinating all aspects of studies under the supervision of a principal investigator (PI). The CRC 1 works under the direction of Dr. Ritu Verma, Dr. Amelia Kellar, other PIs in the Section, and the leadership within the Pediatric Clinical Trials Office. The CRC 1 will be involved in multiple research trial types: biobanking, registry, observational, and multi-institutional pharmaceutical trials implemented and coordinated in the Section. Clinical research tasks may also include study concept development, protocol development and writing, study administration and data collection for an investigator-initiated trial and other new research projects developed by the PIs.
Responsibilities
Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance with study sponsor, PI, and regulatory agency specifications. Ensures compliance with federal regulations and institutional policies. Coordinates all aspects of conducting clinical trials including: recruitment, screening, enrollment, education about study procedures, subject follow-up, completion of the case report form, and adverse event reports. Participates in study-related documentation, such as protocol worksheets, procedural manuals, institutional review board documents, or progress reports. Aliquot and prepare experimental and clinical samples for freezing. Ensures accurate storage for all specimen types, including blood and plasma samples. Maintains accurate and complete documentation of signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), and study-related communication. 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 preparation of IRB submissions independently. Accountable for all tasks in basic clinical studies. Assists with various professional, organizational, and operational tasks under direct supervision. Supports quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups. 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 Apply tot his job Apply To this Job