Job Description
Department
BSD PED - Clinical Trials Office - Research Support
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 Coordinator (CRC) 1 in Pediatrics provides support to the Section of Pediatric Gastroenterology. The CRC 1 will be involved in coordinating all aspects of studies under the supervision of a principal investigator (PI). The CRC 1 works under the direction of Dr. Ritu Verma, Dr. Amelia Kellar, other PIs in the Section, and the leadership within the Pediatric Clinical Trials Office. The CRC 1 will be involved in multiple research trial types: biobanking, registry, observational, and multi-institutional pharmaceutical trials implemented and coordinated in the Section. Clinical research tasks may also include study concept development, protocol development and writing, study administration and data collection for an investigator-initiated trial and other new research projects developed by the PIs.
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.
- Aliquot and prepare 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.
- 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.
- 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: Minimum requirements include knowledge and skills developed through < 2 years of work experience in a related job discipline.
Certifications: --- Preferred Qualifications Education: Experience: - 1-year clinical research experience or relevant experience.
Preferred Competencies - Excellent written and oral communication skills, including the ability to follow written and verbal instructions.
- Strong interpersonal skills with the ability 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 skill development.
- Ability to prioritize tasks, manage multiple deadlines, and maintain attention to detail.
- Proficient in data management and knowledgeable in Microsoft Word, Excel, and Adobe Acrobat.
- Ability to read and comprehend complex documents (e.g., 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 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
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.
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Job Tags
Full time, Work experience placement, Work at office