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BSD PED - Clinical Trials Office: COG and HemOnc Research

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) 2 in Pediatrics provides support to the Solid Tumor Phase 1 and Industry-sponsored studies within the Section of Hematology/Oncology within the Department of Pediatrics. 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. The Clinical Research Coordinator 2 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.

Our department follows a hybrid work structure that fosters productivity, collaboration, and employee well-being. Working from the office is encouraged for tasks that require a high degree of collaboration.

This at-will position is wholly funded by contractual grant funding which is renewed under provisions set by the grantor of the contract. Employment will be contingent upon the continued receipt of these grant funds and satisfactory job performance.

Responsibilities

Manages 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.

Collect, process, ship and store specimens to appropriate laboratory according 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 closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.

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.

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

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

Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF\'s), drug dispensing logs, 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.

Ensures compliance with federal regulations and institutional policies.

May prepare and maintain protocol submissions and revisions.

May assist in the training of new or backup coordinators.

Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.

Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse ev