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BSD PED - Clinical Trials Office: Grant Projects

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 serves as a project coordinator and provides specialized research support to the Principal Investigator (PI), Dr. Tara Henderson, and under the direction of the leadership within the Pediatric Clinical Trials Office. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC 2 oversees, facilitates and coordinates the daily activities of complex clinical trials and plays a critical role in the conduct of the studies to ensure compliance with federal and institutional regulations. Oversees day-to-day operations including identifying & securing needed resources; creating, implementing, monitoring, & updating project plans; facilitating meetings with appropriate parties; tracking tasks/deliverables to ensure timelines, milestones &/or goals are attained; monitoring & reporting progress as appropriate; & resolving or escalating issues in a timely manner. By performing these duties with limited supervision and/or guidance, the CRC 2 works with the PI, department, 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.

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

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.

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

Oversees day-to-day operations including identifying & securing needed resources; creating, implementing, monitoring, & updating project plans; facilitating meetings with appropriate parties; tracking tasks/deliverables to ensure timelines, milestones &/or goals are att ined; monitoring & reporting progress as appropriate; & resolving or escalating issues in a timely manner.

Assist with or plan and implement the clinical study\'s goals and objectives; organize patient enrollment planning; conduct quality assurance activities, compile and analyze data.

Act as a liaison with medical staff, university departments, ancillary departments and/or satellite facilities.

Serve as a resource person or act as a consultant within area of clinical expertise.

Act as a leader within the department/unit through improving clinical research practice and serving as a resource.

Maintain working knowledge of current protocols, and internal SOPs.

Be accountable for high standards of clinical research practice and assist in the development of accountability in others.

Develop and implement procedures, maintain records, track progress, and conduct quality assurance on data collected.

Oversee and participate in the coordination and conduct of complex clinical research studies and ensure compliance with federal and institutional regulations.

Prepare, submit, and assist Investigators with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).

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