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 will primarily support Pediatric Hematology and Oncology clinical research studies.
The Clinical Research Coordinator 2 (CRC) 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 CRC2 supports, facilitates and coordinates independently the daily clinical research activities and plays a critical role in the conduct of the study. By performing these duties with limited supervision and/or guidance, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.
- Maintains a safe research environment and ensures compliance with governmental and University policies, procedures and regulations.
- Controls the acquisition/collection, abstraction, processing, privacy, and quality assurance for all clinical research data required for the protocol. Responsibilities include, but are not limited to, provides efficient and complete data collection, processing, analysis and reporting; assures source documentation and data abstraction and entry are being done at the protocol specified time-points; ensures data accuracy and integrity by working closely with internal monitors and/or auditors to promptly resolve any data quality concerns or outstanding queries; and, facilitates the exchange of data across projects and organizations.
- Protect patient and data confidentiality by ensuring security of research data and protected health information (PHI) and compliance with federal regulations and sponsor protocols.
- Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, PI, and regulatory agency specifications.
- Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.
- Performs various aspects of clinical research, such as collecting and processing specimens, interviewing subjects, taking vital signs, and contributing to the case report.
- 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 ---
- Clinical research experience or relevant experience
- Experience coordinating multiple studies (e.g., investigator initiated, industry sponsored, and multi-site trials).
- Ability to communicate with tact and diplomacy.
- Strong organizational skills.
- Strong communication skills (verbal and written).
- Ability to communicate with tact and diplomacy.
- Ability to handle sensitive matters with tact and discretion.
- Excellent interpersonal skills.
- Strong data management skills and attention to detail.
- Ability to participate in protocol review and clinical trial evaluations.
- Knowledge of medical terminology/environment.
- Ability to handle competing demands with diplomacy and enthusiasm.
- Excellent time management and ability to prioritize work assignments.
- Familiarity with Good Clinical Practices (GCP)
- Understanding of the federal research regulations and the ability to identify the federal research organizations' role in regulating human research participation.
- Adaptability to changing working situations and work assignments.
- Ability to prioritize work and meet deadlines.
- Ability to pay attention to detail.
- 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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