Job Description

Department
BSD PED - Clinical Trials Office

About the Department
In the Department of Pediatrics at the University of Chicago, we strive to provide the highest level of complex care for children from diagnosis and treatment to conducting research to find promising new therapies with a focus on teaching. We are committed to advancing the frontiers of knowledge, and the education and training of future clinical pediatricians, subspecialists, educators, clinical investigators and physician-scientists. The Department of Pediatrics is a dynamic, stimulating place to work, and because we are focused on growth and improved excellence, our staff have particularly challenging and rewarding roles.

The Pediatric Clinical Trials Office (Peds CTO) is an existing centralized support office that provides services and high-level guidance to individuals (faculty, investigators, research staff, and clinic coordinators from the University and Hospital) involved in human subjects research. The Peds CTO is responsible for establishing standards, operating procedures, policies and practices, implementing educational and training programs, developing communication tools, and managing the administrative functions that impact individuals involved in clinical research.

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)

When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.

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

FLSA Status
Exempt

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.

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 [click to reveal phone number]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.

The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: . Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.

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