Clinical Research Coordinator I

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 (CRC I) 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.

Responsibilities

• 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 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:

• Knowledge of medical terminology/environment.

Preferred Competencies

• Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.

• Ability to communicate with tact and diplomacy.

• Strong organizational skills.

• Strong communication skills (verbal and written).

• Excellent interpersonal skills.

• Strong data management skills and attention to detail.

• Knowledge of Microsoft Word, Excel and Adobe Acrobat.

• Ability to understand complex documents (e.g., clinical trials).

• Ability to handle competing demands with diplomacy and enthusiasm.

• Ability to absorb large amounts of information quickly.

• Adaptability to changing working situations and work assignments.

Working Conditions

• Onsite - Direct Patient Contact.

Application Documents

• Resume (required)

• Cover Letter (preferred)

Job Family

Research

Role Impact

Individual Contributor

Scheduled Weekly Hours

40

Drug Test Required

Yes

Health Screen Required

Yes

Motor Vehicle Record Inquiry Required

No

Pay Rate Type

Salary

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FLSA Status

Exempt

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Pay Range

$50,000.00 - $65,000.00

The included pay rate or range represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting.

Benefits Eligible

Yes

The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.

Posting Statement

The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.

 

Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via Applicant Inquiry Form.

 

All offers of employment are contingent upon a background check that includes a review of conviction history.  A conviction does not automatically preclude University employment.  Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.

 

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