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BSD PED - Clinical Trials Office

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 Pediatric Clinical Research Coordinator 1 provides support to the Section of Allergy/Immunology and Pediatric Pulmonology. The CRC will be involved in coordinating all aspects of studies under the supervision of a PI. The Clinical Research Coordinator 1 works under the direction of Dr. Christina Ciaccio, Dr. Elizabeth Carr, Dr. So Lim Kim, and the leadership within the Pediatric Clinical Trials Office. Clinical research tasks may 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.

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

Ensures accurate storage for all specimen types.

Coordinates 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.

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.

Perform experiments, collect, analyze, and interpret 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.

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

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.

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.

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 low-complexity 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. Aliquot and prepare experimental and clinical samples for freezing.

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