Department

BSD PED - Clinical Trials Office

Job Summary

The Clinical Research Nurse works in the Department of Pediatrics under the supervision of the Clinical Research Director, Department of Pediatrics Medical Director, and the Principal Investigator(s) (PI) of assigned studies. This position will play a central role in the conduct of investigator-initiated and industry-sponsored clinical trials across all Pediatric Sections and research service lines, including (but not limited to) Pediatric Allergy, Immunology, and Pulmonology; Cardiology; Critical Care; Developmental and Behavioral Pediatrics; GI; Infectious Disease; Neonatology; Neurology; Pediatric Hematology and Oncology; Rheumatology. This role bridges clinical care and research operations, ensuring high-quality, ethical, and protocol-compliant study conduct while supporting patient-centered trial participation. These research trials (both established and future) will include multi-centered cooperative group and intergroup trials at a national level, multi-institutional pharmaceutical trials, and single and multi-centered trials, designed, implemented, and coordinated in the Department.

Responsibilities

• Ensure compliance with each study’s protocol by providing thorough review and documentation at each subject study visit.

• Participate in recruitment and selection of study participants by interviewing and documenting medical history to determine compliance with eligibility requirements.

• Perform medical tests, collect labs, and administer investigational medications and perform patient assessments during clinic visits to determine presence of side effects; notify Principal Investigator of findings/issues.

• Provide patient education and medical information to study patients to ensure understanding of proper medication dosage, administration, and disease treatment.

• Document medical data in patient chart to capture protocol requirements. Provide accurate and timely data collection, documentation, entry, and appropriate reporting to sponsors and institutions.

• Support regulatory components and site research compliance for study feasibility, study start-up, ongoing study monitoring, and site close out. 

• Provide training and mentorship to clinical research team on clinical trial assessments, best practices for clinical research visits, and ALOCA+ data maintenance. 

• Serve as liaison between PI, sponsoring agent, regulatory groups, patient, family members, referring MD's/community MD's, pharmacist, statistician, and other members of the research team.

• Interprets information from caregivers, nurses, or physicians about patient condition, treatment plans, or appropriate activities.

• Has a solid understanding of the information and techniques needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventive health-care measures.

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

Certifications:

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Preferred Qualifications

Education:

• Bachelor of Science Degree in Nursing.

Experience:

• Experience with obtaining consent and assent, and supporting clinical teams in regulatory preparation (IRB applications, amendments, informed consent).

• Experience with industry sponsored clinical trials and the regulatory components of those studies. 

• Two years of clinical nursing experience with demonstrated clinical competence in patient care, teaching and management of patient treatment plans, and knowledge about clinical research including protocol therapy and data management.

Licenses and Certifications:

• Current licensure as a registered nurse in the State of Illinois from the National Council Licensure Examination for Registered Nurses (NCLEX).

• Registered Nurse with a current Illinois license.

Preferred Competencies

• Fundamental working knowledge of clinical research.

• Ability to train internal staff, coordinate compliance, and participate in audits/inspections to address regulatory findings. 

• Knowledge and ability to provide direct patient care, including aseptic techniques, in a professional and respectful manner.

• Excellent verbal and written communication, and ability to read relevant documents and instruments.

• Ability to perform multiple concurrent tasks with occasional interruptions and adapt to changing working situations and work assignments.

• Ability to exercise discretion and confidentiality while handling sensitive situations.

• Ability to solve problems by applying math or reasoning principles.

Application Documents

• Resume (required)

• Cover letter (required)

Job Family

Healthcare & Medical Services

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

$70,000.00 - $100,000.00

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.