Coordinate all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of case report forms (CRFs), and adverse event (AE) reporting.
Maintain accurate and complete documentation of signed informed consent, relevant IRB approvals, source documentation, CRFs, drug/device accountability logs, and study-related communication.
Perform specific protocol procedures (specimens and data management, survey/questionnaire administration, etc.) required to conduct the study and retain research subjects.
Understand protocols and assist with identifying, collecting, and reporting adverse events (AEs) per protocol or investigator brochure.
Plan and coordinate patient schedules for study procedures, return visits, and study treatment timelines.
Ensure Standard Operating Procedures (SOPs) are implemented and documented in accordance with study sponsor, PI, and regulatory agency requirements.
Prepare, submit, and maintain regulatory documentation, including IRB submissions, amendments, continuing reviews, and study-related materials.
Assist investigators and research staff with reports to regulatory agencies (e.g., IRB, FDA, Data and Safety Review Committee).
Educate patients about study procedures, visit schedules, reporting requirements, and potential side effects.
Perform visit-related assessments and monitor participants for adverse events.
Organize and attend site visits from sponsors, including monitoring visits, audits, and other study-related meetings.
Prepare for and participate in quality assurance audits conducted by study sponsors, federal agencies, or internal review groups.
May recruit and screen potential study participants; may obtain, process, and transport specimens according to protocol and institutional guidelines.
Act as a liaison with clinical staff, investigators, and ancillary departments to support study conduct.
Maintain working knowledge of study protocols, manuals of operations, and internal SOPs.
Follow procedures, maintain study records, track progress, and respond to data queries in a timely manner.
Support clinical data management activities, including data collection, entry, verification, and query resolution; assist with retrieval of patient data and preparation of research charts.
Assist with implementation of study goals and objectives, including enrollment planning and quality assurance activities.
Accountable for all tasks in basic to moderately complex clinical studies.
Use knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples.
Accountable for all tasks in basic 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.
Performs other
Benefits
Vision insurance
Additional Information
Department
BSD OCR - Clinical Research Operations
About the Department
The Office of Clinical Research (OCR) was created to further the research missions of the University of Chicago Biological Sciences Division and the University of Chicago Medical Center. The office's mission is to catalyze clinical research by providing expertise, resources, infrastructure, and systems that facilitate clinical research operations and enable collaboration across the enterprise while promoting compliance and human subject protection. To do this, the work of the OCR is supported by five service units: Human Subject Protection (IRB); Research Compliance; Clinical Research Operational Excellence; Clinical Research Incubation; and Clinical Trial Finance.
Job Summary
The job performs routine assignments related to the documentation and reporting of basic clinical studies. Supports decisions that impact clinical research conducted across the University.
The Clinical Research Coordinator I- Office of Clinical Research (OCR) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). While the Principal Investigator is primarily responsible for the overall design, conduct, and management of clinical research projects, the CRC I supports, facilitates, and coordinates the daily activities of clinical research and plays a key role in the conduct of studies to ensure compliance with federal and institutional regulations.
This position is housed within the Bridge Support Unit and will work directly with investigators in one or more clinical departments or specialties. The CRC I is responsible for executing study procedures in accordance with protocol requirements, including participant screening, enrollment, study visits, data collection, and regulatory documentation. By performing these duties, the CRC I works with the PI, department, sponsor, and institution to support and ensure compliant study conduct, while contributing to the overall administration of regulatory, operational, and study-related activities.
Uchicago · Chicago, IL