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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 (CRC) 2 provides support to the Section of Rheumatology within the Department of Pediatrics. The CRC2 will be involved in multiple research trials 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 PI and leadership within the Pediatric Clinical Trials Office.

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.

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 ensuring 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 approv ls, 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.

Assists with and performs various administrative and operational tasks under moderate to limited 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. Contribute to the problem-solving on assigned clinical research studies and tasks.

Analyzes, facilitates and participates in the daily