BSD PED - Clinical Trials Office: Hematology, Oncology, and Stem Cell Transplantation
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. This position is wholly funded by contractual grant funding which is renewed under provisions set by the grantor of the contract. Employment will be contingent upon the continued receipt of these grant funds and satisfactory job performance.
The Clinical Research Project Coordinator (CRPC) is a specialized researcher partnering with the Principal Investigator (PI) and under the direction of a departmental research manager. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRPC oversees, facilitates and coordinates the daily activities of complex clinical trials and plays a critical role in the conduct of the studies to ensure compliance with federal and institutional regulations. Oversees day-to-day operations including identifying & securing needed resources; creating, implementing, monitoring, & updating project plans; facilitating meetings with appropriate parties; tracking tasks/deliverables to ensure timelines, milestones &/or goals are attained; monitoring & reporting progress as appropriate; & resolving or escalating issues in a timely manner. By performing these duties with limited supervision and/or guidance, the CRPC works with the PI, department, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.
- Oversees day-to-day operations including identifying & securing needed resources; creating, implementing, monitoring, & updating project plans; facilitating meetings with appropriate parties; tracking tasks/deliverables to ensure timelines, milestones &/or goals are attained; monitoring & reporting progress as appropriate; & resolving or escalating issues in a timely manner.
- Assist with or plan and implement the clinical study's goals and objectives; organize patient enrollment planning; conduct quality assurance activities, compile and analyze data.
- Act as a liaison with medical staff, university departments, ancillary departments and/or satellite facilities.
- Serve as a resource person or act as a consultant within area of clinical expertise.
- Act as a leader within the department/unit through improving clinical research practice and serving as a resource.
- Maintain working knowledge of current protocols, and internal SOPs.
- Be accountable for high standards of clinical research practice and assist in the development of accountability in others.
- Develop and implement procedures, maintain records, track progress, and conduct quality assurance on data collected.
- Oversee and participate in the coordination and conduct of complex clinical research studies and ensure compliance with federal and institutional regulations.
- Prepare, submit, and assist Investigators with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
- Provide Investigators with guidance regarding protocol requirements.
- Maintain regulatory documentation.
- Assist other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety Review Committee.
- Prepare for and assist with audits, inspections, and monitoring visits from regulatory agencies or sponsors.
- Attend continuing education and training opportunities relevant to job duties.
- Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.
- Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.
- Performs other related work as needed.
Minimum requirements include a college or university degree in related field.---
Minimum requirements include knowledge and skills developed through ---
- 2-5 years of clinical research experience coordinating multiple and variety of studies (e.g., investigator initiated; industry sponsored; multi-site trials).
- Ability to participate in protocol review and clinical trials evaluations.
- Excellent interpersonal skills.
- Strong data management skills and attention to detail.
- Strong organizational skills.
- Experience in managing NIH funded grants.
- Ability to handle competing demands with diplomacy and enthusiasm.
- Ability to work collaboratively with faculty and divisional clinical research infrastructure.
- Excellent time management and ability to prioritize work assignments.
- Ability to read and understand clinical trials protocols.
- Familiarity with medical terminology/environment.
- Working knowledge of Good Clinical Practices (GCP).
- Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat.
- 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
Individual ContributorFLSA Status
MonthlyScheduled Weekly Hours
YesDrug Test Required
YesHealth Screen Required
YesMotor Vehicle Record Inquiry Required
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Staff 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.
We seek a diverse pool of applicants who wish to join an academic community that places the highest value on rigorous inquiry and encourages a diversity of perspectives, experiences, groups of individuals, and ideas to inform and stimulate intellectual challenge, engagement, and exchange.
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