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BSD OCR - Clinical Research Incubation

About the Department

The Office of Clinical Research (OCR) is dedicated to supporting the infrastructure for the management and administration of clinical research at The University of Chicago as well as individual research programs with the goal of improving communication, consistency, and collaboration across the Biological Sciences Division and UChicago Medicine.

The mission of the OCR 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 on behalf of our diverse community of patients and volunteers.

Job Summary

The Clinical Research Coordinator I (CRC1) is a specialized research professional working with and under the direction of the Principal Investigator (PI), Co-investigator(s), and other study personnel to follow the clinical protocol. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of clinical trials, the CRC 1 is delegated to perform study related tasks across the life cycle of the study. The CRC1 plays a critical role in the conduct of the studies to ensure compliance with federal and institutional regulations. This position is housed within a central core but will work specifically with investigators in the Orthopedic Surgery Department. By performing these duties, the CRC 1 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 studies.

Responsibilities

Regulatory:

• 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).
• Follow protocol manual of operations.
• Maintain regulatory documentation.
• Assist other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety Review Committee.
• Prepare for and assist with audits, inspections, and monitoring visits from regulatory agencies or sponsors.

Research Conduct/Study Management:

• 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 clinical staff, university departments, ancillary departments and/or satellite facilities.
• Serve as a resource person or act as a consultant within area of clinical expertise.
• Support the department/unit with active quality improvement activities in 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.

Data Management:

• Follow procedures, maintain records, track progress, and respond to data queries in timely manner.
• 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.
• Understands protocols and advises treating physicians on appropriate dosage modificati ns or treatment calculations based on patient characteristics.
• 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 other related work as needed.

Minimum Qualifications

Education:

Minimum requirements include vocational training, apprenticeships or the equivalent experience in related field (not typically required to have a four-year degree).

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Work Experience:

Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.

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Certifications:

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Preferred Qualifications

Education:

• A college or university degree in related field.

Experience:

Knowledge and skills developed through 2-5 years of work experience in a related job discipline.