Clinical Research Coordinator - Pediatrics

Department

BSD PED - Clinical Trials Office: COG and Hem Onc Research

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.

The Clinical Research Coordinator (CRC) 2 in Pediatrics provides support to the Section of Hematology and Oncology within the Department of Pediatrics. The CRC2 works under the general direction of the Director of Clinical Research, the PI, and the study team. The CRC2 will be involved in an Investigator‑Initiated Trial and biobanking study.

• Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications, ensuring compliance with federal regulations and institutional policies.
• Coordinates and may participate in quality assurance reviews, including site visits, monitoring visits, and audits conducted by study sponsors, federal agencies, or specially designated review groups.
• Understands the IRB submission and review process and knows 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.
• Collects, processes, ships and stores specimens to appropriate laboratory according to established aseptic techniques.
• Prepares program conference lists for multidisciplinary conferences and workshops.
• May assist in the training of new or backup coordinators.
• Accounts for all tasks in moderately complex clinical studies.
• Assists with various professional, organizational, and operational tasks under moderate supervision.
• Facilitates and participates in the daily activities of moderately complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits.
• Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a limited to moderate degree of independence. Contributes to problem solving on assigned clinical research studies and tasks.
• Performs other related work as needed.

Minimum Qualifications: College or university degree in a related field.

Minimum Qualifications: Knowledge and skills developed through 2–5 years of work experience in a related job discipline.

• Bachelor’s Degree.

• 2 years of clinical research experience coordinating multiple and variety of studies (e.g., investigator‑initiated; industry‑sponsored; multi‑site trials).
• 1 year previous experience managing NIH funded grants.

• Ability to communicate in writing and orally; follow written and verbal instructions; comprehend and read complex technical and clinical documents.
• Ability to develop and manage interpersonal…