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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.

To 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 Office of Clinical Research, through the Clinical Research Incubation Unit, provides research conduct, data management, and regulatory services to departments, sections, and units who are building their research portfolio or who need bridge support during a high growth period or during periods of staffing transitions. The OCR Clinical Research Incubation unit provides expertise, infrastructure, staff onboarding, staff training, project management, and staff management for research units in the growth and maintenance stages.

The Clinical Research Coordinator 2 (CRC2) 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 2 is delegated to perform study related tasks across the life cycle of the study. The CRC2 plays a critical role in the conduct of the studies to ensure compliance with federal and institutional regulations. This position is housed within the Clinical Research Incubation Unit but will work directly with investigators in one or more clinical departments or specialties. The CRC 2 acts as a key communicator, project manager, and clinical research conduct knowledge partner alongside the investigator, sponsor, and institution to support compliance, financial, personnel and other related aspects of the clinical studies.

Responsibilities

• 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).
• Act as a liaison with clinical staff, university departments, ancillary departments and/or satellite facilities.
• Maintain working knowledge of current protocols, and internal SOPs. Develop standard work to support efficient workflows.
• Be accountable for high standards of clinical research practice and assist in the development of accountability in others.
• 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.
• Solves a range of straightforward problems relating to the administration of the compliance, financial and other related aspects of a clinical study.
• Facilitates and participates in the daily activities of moderately complex clinical studies and performs various activ ties 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. Contributes to the problem solving on assigned clinical research studies and tasks.
• Performs other related work as needed.

Minimum Qualifications

Education:

Minimum requirements include a college or university degree in related field.

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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:

• College or university degree in related field.

Experience:

• 2-5 years of work experience in a related job discipline.

Preferred Competencies

Strong knowledge of clinical research regulations and best practices.

Excellent time management and ability to prioritize work assignments.

Ability to read