Clinical Research Coordinator I (CRC 1)- Office of Clinical Research (OCR)

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. The OCR works through five service units: Human Subject Protection (IRB); Research Compliance; Clinical Research Operational Excellence; Clinical Research Incubation; and Clinical Trial Finance. Department BSD OCR - Clinical Research Operations Job Summary The Clinical Research Coordinator I (CRC I) supports routine assignments related to the documentation and reporting of basic clinical studies, facilitates decisions that impact clinical research conducted across the University, and works with investigators in one or more clinical departments or specialties. The CRC I executes study procedures in accordance with protocol requirements, including participant screening, enrollment, study visits, data collection, regulatory documentation, and maintains complete documentation of signed consents, IRB approvals, source documentation, case report forms, drug/device accountability logs, and study‑related communication. The CRC I ensures compliance with federal and institutional regulations, manages patient schedules, prepares regulatory submissions, performs adverse event reporting, supports quality assurance audits, and may recruit and screen study participants. Responsibilities Coordinate all aspects of clinical trials, including screening, enrollment, subject follow‑up, case report form completion, and adverse event reporting. Maintain accurate documentation of informed consent, IRB approvals, source docs, CRFs, drug/device accountability logs, and study communications. Perform protocol procedures—specimen and data management, surveys—and retain research subjects. Identify, collect, and report adverse events per protocol or investigator brochure. Plan and coordinate patient schedules for study procedures, return visits, and treatment timelines. Implement and document SOPs in accordance with sponsor, PI, and regulatory requirements. Prepare, submit, and maintain regulatory documentation, including IRB submissions, amendments, continuing reviews, and related materials. Assist investigators and research staff with reports to regulatory agencies such as IRB, FDA, and 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 sponsor site visits, audits, and other study‑related meetings. Prepare for and participate in quality assurance audits conducted by sponsors, federal agencies, or internal review groups. Recruit and screen potential study participants; obtain, process, and transport specimens per protocol and institutional guidelines. Act as liaison with clinical staff, investigators, and ancillary departments to support study conduct. Maintain knowledge of protocols, manuals of operations, and internal SOPs. Follow procedures, maintain records, track progress, and respond to data queries timely. Support clinical data management: data collection, entry, verification, query resolution, and retrieval of patient data. Assist with implementation of study goals and objectives, including enrollment planning and quality assurance activities. Accountable for tasks in basic and moderately complex studies. Use clinical study knowledge to coordinate collection of analyzable data and/or samples. Perform additional related work as needed. Minimum Qualifications College or university degree in a related field. Less than two years of work experience in a related discipline. Preferred Qualifications Bachelor’s degree. Knowledge of medical terminology or clinical environment. Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others. Diplomacy and tact in communication. Strong organizational skills. Strong verbal and written communication skills. Excellent interpersonal skills. Strong data‑management skills and attention to detail. Proficiency with Microsoft Word, Excel, and Adobe Acrobat. Ability to understand complex documents such as clinical trial protocols. Ability to handle competing demands with diplomacy and enthusiasm. Rapid absorption of large amounts of information. Adaptability to changing work situations and assignments. Working Conditions Onsite – direct patient contact. Job Details 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 FLSA Status: Exempt Pay Range: $50,000.00 – $65,000.00 Benefits Eligible: Yes Benefits 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 any other protected class 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 View phone number on click.appcast.io or submit a request via the 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; the University considers conviction information on a case‑by‑case basis. 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