Clinical Research Coordinator 1
Hyde Park Campus
About the Unit
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. The Clinical Research Coordinator 1 will provide support to the faculty in the section of Neonatology within the Department of Pediatrics. Preterm infants are at risk for poor neurodevelopmental outcome due to their degree of prematurity, hospital course, and home environment. We are studying the changes in the bacterial colonization patterns of these infants in the context of their home environment and to identify a potentially modifiable factor that may influence brain development and thus ensure school readiness for these vulnerable infants. 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 Coordinator 1 (CRC1) works under the general direction of a departmental, clinical research manager and/or the Office of Clinical Research (OCR) in partnership with the Principal Investigator (PI), Co-Investigator(s) and other study personnel. The CRC1 works with the PI, clinical research manager, department, sponsoring agencies, and the OCR to support and provide guidance on the administration of the compliance, financial, and other related aspects of the clinical study. The CRC1 coordinates, completes and monitors the daily clinical trial activities and performs a variety of duties involved in the collection, compilation, documentation and reporting of clinical research data. The CRC1 plays a critical role in ensuring compliance with the study protocol, Federal guidelines, Local guidelines, and in accordance with Good Clinical Practice (GCP).
- Depending on workload, some evening and weekend hours may be required.
- Research Conduct/Study Management:
- Manages all aspects of conducting clinical trials from startup to closeout for one or two clinical trials. Responsibilities include, but are not limited to, recruitment and screening of study subjects, obtaining informed consent, enrollment of subject in research study, subject follow-up, collecting and analyzing research data, completion of the case report form (CRF), adverse event reports and ensuring protocol adherence.
- Plans and coordinates subjects schedule for study procedures, return visits, and study treatment schedules; educates subjects about study procedures to be performed, what to report between and during visits, and the risks and benefits of the procedures; performs assessments at visits and monitors for adverse events.
- Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.
- Independently performs assessments to monitor for and identify adverse events and protocol deviations or violations, and assists PI in reporting to the sponsor and IRB under general direction of department, clinical research manager and/or the Office of Clinical Research.
- Reviews the protocol plan to understand and assist with planning for the various costs and resources required such as clinical care expenses, personnel effort, site initiation costs (IRB fees, pharmacy costs, etc.), equipment, and supplies.
- Organizes and actively participates in site visits from sponsors and other relevant study meetings.
- Maintains a safe research environment and ensures compliance with governmental and University policies, procedures and regulations.
- Data Management:
- 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.
- Regulatory Compliance:
- Maintains accurate and complete records which may include, but are not limited to, signed informed consent, Institutional Review Board (IRB) communication, source documentation, CRFs, drug dispensing logs, and study related communication.
- May prepare and maintain protocol submissions and revisions.
- Other Duties:
- Other duties as assigned.
- Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others required.
- Ability to communicate with tact and diplomacy required.
- Strong organizational skills required.
- Strong communication skills (verbal and written) required.
- Excellent interpersonal skills required.
- Strong data management skills and attention to detail required.
- Knowledge of Microsoft Word, Excel and Adobe Acrobat required.
- Ability to read and understand complex documents (e.g., clinical trials) required.
- Ability to handle competing demands with diplomacy and enthusiasm required.
- Ability to absorb large amounts of information quickly required.
- Adaptability to changing working situations and work assignments required.
ADDITIONAL JOB DESCRIPTION:
Education, Experience, and Certifications:
- Bachelor's degree required.
- Minimum of 1 year of research experience or relevant experience preferred.
Technical Knowledge or Skills:
- Knowledge of patient evaluation and triage procedures and the ability to monitor clinical research patients from many disciplines preferred.
- Knowledge of medical terminology / environment preferred
- Understanding of the IRB submission and review process and when and how to apply for IRB review preferred
- Understanding of the federal research regulations and the ability to identify the federal research organizations' role in regulating human research participation preferred
Working Conditions and Physical Requirements (if applicable):
- Exposure to human tissue or other biological agents
The following documents are required to be considered for this position:
- Cover Letter
- Professional References
(NOTE: When applying, all required documents, including cover letters, MUST be uploaded under the Resume/CV section of the application.)
Depends on Qualification
Scheduled Weekly Hours
Job is Exempt?
Drug Test Required?
Does this position require incumbent to operate a vehicle on the job?
Health Screen Required?
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