Clinical Research Coordinator 1 - Pediatrics
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.
About the role
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.
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.
- Captures and 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.
- Maintains accurate and complete documentation of signed informed consent, relevant IRB approvals, source documentation, case report forms (CRFs), 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.
Requirements
- Minimum requirements include a college or university degree in related field.
- Minimum requirements include knowledge and skills developed through 1-year clinical research experience or relevant experience.
Qualifications
- Education: Bachelor’s degree.
- Experience: 1-year clinical research experience or relevant experience.
- Technical Skills: Proficient in data management and knowledgeable in Microsoft Word, Excel, and Adobe Acrobat. Read and comprehend complex documents, such as clinical trials.
Skills
- 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.
Benefits
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.