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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 2 (CRC2) provides support to the Section of Pediatric Hematology and Oncology. The CRC2 will be involved in multiple research trials types: investigator-initiated, multi-centered cooperative group studies, multi-institutional pharmaceutical trials, and multi-centered trials designed, implemented, and coordinated in the Section including but not limited to solid tumor and central nervous system research and clinical trials.The CRC2 is a specialized researcher partnering with the Principal Investigator (PI) and under the direction of leadership in the Peds CTO. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC2 supports, facilitates, and coordinates independently the daily clinical research activities and plays a critical role in the conduct of the study. By performing these duties with limited supervision and/or guidance, the CRC2 works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.

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

Analyzes, facilitates and participates in the daily activities of multiple moderately complex clinical trials and performs all aspects of clinical data management, including patient data retrieval, referring MD office records, preparing clinical research charts, and participation in program audits.

Prepares program conference lists for multidisciplinary conferences and workshops. Participates in all pharmaceutical site visits. Uses moderate understanding of clinical trials to collect and store patient specimens, radiology scans and reports.

Solves a range of straightforward problems relating to the administration of the compliance, financial and other related aspects of a clinical study.

Manages all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports 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 th 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