Department
BSD PED - Clinical Trials Office: Neonatology
About the Department
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
This at-will position is wholly funded by extramural funds, such as grant, gift, and endowment, which are renewed under provisions set by the grantor of the funds. Employment will be contingent upon the continued receipt of these funds and satisfactory job performance.
Responsibilities
- Ensures standard operating procedures (SOP) are implemented and documented in accordance with study sponsor, PI, and regulatory agency specifications. Ensures compliance with federal regulations and institutional policies.
- Coordinates all aspects of conducting clinical trials including recruitment, screening, enrollment, education about study procedures, subject follow-up, completion of the case report form, and adverse event reports.
- Participates in study-related documentation, such as protocol worksheets, procedural manuals, institutional review board documents, or progress reports.
- Aliquots and prepares experimental and clinical samples for freezing. Ensures accurate storage for all specimen types, including blood and plasma samples.
- Maintains accurate and complete documentation of signed informed consent, relevant IRB approvals, source documentation, case report forms (CRF's), and study-related communication.
- Understands the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions independently.
- 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:
Certifications:
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Preferred Qualifications
Education:
- Bachelor’s degree.
Experience:
- 1-year clinical research experience or relevant experience.
Technical Skills or Knowledge:
- Proficient in data management and knowledgeable in Microsoft Word, Excel, and Adobe Acrobat.
- Read and comprehend complex documents, such as clinical trials.
Preferred Competencies
- Excellent written and oral communication skills, including follow written and verbal instructions.
- Strong interpersonal skills to work independently and collaboratively as part of a team.
- Demonstrated discretion, tact, and professionalism in handling confidential and sensitive matters.
- Adaptable and committed to ongoing learning and skills development.
- Prioritize tasks, manage multiple deadlines, and maintain attention to detail.
Application Documents
- Resume/CV (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
Role Impact
Scheduled Weekly Hours
Drug Test Required
Health Screen Required
Motor Vehicle Record Inquiry Required
Pay Rate Type
FLSA Status
Pay Range
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
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.
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: http://securityreport.uchicago.edu. Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.
Skills Required
- College or university degree in related field.
- Knowledge and skills developed through < 2 years of related work experience.
- Resume/CV and Cover Letter must be submitted via application.
- Bachelor's degree.
- 1-year clinical research experience or relevant experience.
- Proficient in data management and Microsoft Word, Excel, and Adobe Acrobat.
- Ability to read and comprehend complex clinical trial documents and protocols.
- Excellent written and oral communication, interpersonal skills, discretion, adaptability, and ability to prioritize tasks.
What We Do
The University of Chicago is an urban research university that has driven new ways of thinking since 1890. Our commitment to rigorous inquiry and intellectual freedom draws pathbreaking scholars to our global campuses, where field-defining ideas are born that challenge and change the world. The University of Chicago has its main campus on Chicago's South Side and seven international campuses and centers throughout the world. Students can choose from 53 majors and 47 minors in the undergraduate College, with four divisions and seven professional schools for graduate study.
