Department
BSD PED - Clinical Trials Office
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
Responsibilities
Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications, ensuring compliance with federal regulations and institutional policies. Coordinates and may participate in quality assurance reviews, including site visits, monitoring visits, and audits conducted by study sponsors, federal agencies, or specially designated review groups.
Understand 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.
Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.
Prepares program conference lists for multidisciplinary conferences and workshops.
May assist in the training of new or backup coordinators.
Accountable for all tasks in moderately complex clinical studies.
Assists with various professional, organizational, and operational tasks under moderate supervision.
Facilitates and participates in the daily activities of moderately complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits.
Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a limited to moderate degree of independence. Contributes to the problem solving on assigned clinical research studies and tasks.
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:
2 years of clinical research experience coordinating multiple and variety of studies (e.g., investigator-initiated; industry-sponsored; multi-site trials).
Preferred Competencies
Ability to communicate in writing and orally; follow written and verbal instructions; comprehend and read complex technical and clinical documents.
Ability to develop and manage interpersonal relationships; work effectively, independently, or as part of a team; collaborate with faculty and divisional clinical research infrastructure; demonstrate excellent interpersonal skills.
Ability to exercise absolute discretion regarding confidential matters, sensitive, or stressful matters; handle competing demands with diplomacy and enthusiasm; maintain high alertness and respond calmly and rationally to conflicts or emergencies.
Ability to prioritize multiple tasks, manage time efficiently, meet deadlines, and maintain strong organizational skills; work independently; learn and develop new skills.
Strong data management skills and attention to detail; familiarity with medical terminology and Good Clinical Practices (GCP); extensive knowledge of Microsoft Word, Excel, and Adobe Acrobat; understanding of federal research regulations and human research protections; ability to participate in protocol review and evaluate clinical trials.
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
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.
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Skills Required
- College or university degree in related field
- 2-5 years of related work experience in clinical research or related discipline
- Bachelor's Degree
- 2 years of clinical research experience coordinating multiple study types (investigator-initiated, industry-sponsored, multi-site)
- Familiarity with medical terminology and Good Clinical Practices (GCP)
- Extensive knowledge of Microsoft Word, Excel, and Adobe Acrobat
- Ability to communicate effectively in writing and orally; comprehend complex technical and clinical documents
- Strong data management skills and attention to detail
- Ability to prioritize tasks, manage time efficiently, and meet deadlines
- Ability to exercise discretion regarding confidential or sensitive matters
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.
