Clinical Research Coordinator I

Department

BSD DFI - Clinical Studies

About the Department

The Duchossois Family Institute (DFI) at the University of Chicago Medicine promotes wellness through groundbreaking science on the immune system, genetics, the microbiome, and their shared environments. Introducing a new science of wellness, the DFI aims to maximize good health and the economic, social, and personal benefits it delivers. The DFI comprises a multidisciplinary team of scientists, physicians, data analysts, and entrepreneurship specialists who work together to accelerate development of this innovative, paradigm-shifting approach to health.

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 DFI performs microbiome analyses on patients undergoing heart and/or liver transplantation, cancer treatment and intensive care hospitalization under protocols that have been approved the University of Chicago IRB. The clinical research coordinator will assist in all aspects of the clinical research studies to ensure compliance with protocol and applicable institutional and regulatory guidelines. It is anticipated that the findings of these studies will lead to the optimization of patient recovery from complex medical therapies, with reduced complication rates, including antibiotic-resistant infections, and shortened hospital stays.

Responsibilities

• Support all aspects of clinical trial operations, including participant screening, enrollment, follow-up, completion of case report forms, adverse event reporting, and protocol compliance.

• Obtain in-person patient consent.

• Transport patient specimens from the clinics or hospital units to the research laboratory.

• Coordinate with couriers for sample collection from home to hospital.

• Perform data entry and statistical analyses, including data collection, summary statistics, and sample collection metrics.

• Assist in developing source documentation, subject and specimen tracking systems, and REDCap forms. 

• Call patients for survey completion and appointment reminders. 

• Support enrollment, data collection, specimen tracking, adverse event monitoring, and other assigned tasks in Phase 1 clinical trial.

• Serve as a liaison between medical staff, university departments, and ancillary teams.

• Maintain accurate, complete records, including signed consent forms, relevant IRB approvals, source documentation, case report forma, drug dispensing logs, and study communications.

• Remain current with study protocols and internal SOPs.

• Uphold high standards in clinical research practice and help foster accountability in the team.

• Ensure compliance with federal regulations and institutional policies.

• Accountable for all tasks in basic clinical studies.

• Assists with various professional, organizational, and operational tasks under direct supervision.

• Supports quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.

• Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples.

• Performs other related work as needed.

Minimum Qualifications

Education:

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

Work Experience:

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

Certifications:

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Preferred Qualifications

Education:

• Bachelor’s degree.

Experience:

• Prior experience coordinating multiple studies is strongly preferred.

• Proficient in using computers, databases and Excel; familiarity with REDCap and EPIC is a plus.

• Bilingual Spanish-speaking skills are advantageous.

Preferred Competencies

• Ability to communicate clearly, tactfully, and courteously with patrons, patients, staff, faculty, students, and others.

• Genuine interest in health disparities research.

• Strong organizational skills.

• Excellent verbal and written communication skills.

• Outstanding interpersonal skills.

• Strong data management skills and meticulous attention to detail.

• Proficient in Microsoft Word, Excel, PowerPoint, Adobe Acrobat.

• Ability to perform bas