University of Chicago Clinical Research Coordinator 1 in Chicago, Illinois
Please make sure to read the job posting in its entirety as it reflects both the University roles and responsibilities, followed by the specific description.
2013024 Pediatrics-Clearing Accounts
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.
Responsible for all aspects of research projects and research facilities. Plans and conducts clinical and non-clinical research; facilitates and monitors daily activities of clinical trials or research projects. Directs engineering and technical support activities to develop and maintain tools and computational methods needed to gather and analyze data.
Career Track and Job Level
Manages, facilitates, and monitors the daily activities of clinical research and clinical trials. Performs a variety of duties involved in the collection, documentation, analysis and reporting of clinical research and clinical trial data. Manages the strategic, administrative, operational, and financial decisions that impact clinical research and clinical trials conducted across the University.
T2: Expands skills in own work area within an analytical/scientific method or operational process. Maintains appropriate licenses, training and/or certifications, as needed. Applies experience and skills to complete assigned work within our area of expertise. Works within standard operating procedures and/or scientific methods. Works with a moderate degree of supervision.
The job provides technical support activities related to documents, analyzes, and reports on clinical research data. Provides input to support the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University.
1) Perform specific protocol procedures such as interviewing subjects, taking vital signs, and performing electrocardiograms., 2) Understands protocols and advises treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics., 3) Prepares for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups., 4) Participates in study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports., 5) Performs other related work as needed.
1) 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.
2) 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.
3) Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.
4) Independently performs assessments to monitor for and identify adverse events and protocol deviations or violations, noting severity and causality and attribution of the adverse events; reports findings to PI, sponsor and IRB under general direction of department, clinical research manager and/or the Office of Clinical Research.
5) 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.
6) Organizes and actively participates in site visits from sponsors and other relevant study meetings.
7) Maintains a safe research environment and ensures compliance with governmental and University policies, procedures and regulations.
8) 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.
9) Protect patient and data confidentiality by ensuring security of research data and protected health information (PHI) and compliance with federal regulations and sponsor protocols.
10) Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, PI, and regulatory agency specifications.
11) Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant Institutional Review Board (IRB) approvals, source documentation, CRFs, drug dispensing logs, and study related communication.
12) May prepare and maintain protocol submissions and revisions.
1) Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.
2) Ability to communicate with tact and diplomacy.
3) Strong organizational skills.
4) Strong communication skills (verbal and written).
5) Excellent interpersonal skills.
6) Strong data management skills and attention to detail.
7) Knowledge of Microsoft Word, Excel and Adobe Acrobat.
8) Ability to read and understand complex documents (e.g., clinical trials).
9) Ability to handle competing demands with diplomacy and enthusiasm.
10) Ability to absorb large amounts of information quickly.
11) Adaptability to changing working situations and work assignments.
12) Knowledge of patient evaluation and triage procedures and the ability to monitor clinical research patients from many disciplines.
13) Knowledge of medical terminology / environment.
14) Understanding of the IRB submission and review process and when and how to apply for IRB review.
15) Understanding of the federal research regulations and the ability to identify the federal research organizations’ role in regulating human research participation.
Education, Experience, and Certifications
Minimum requirements include vocational training, apprenticeships or the equivalent experience in related field (not typically required to have a four-year degree).
Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.
1) Bachelor’s degree
1) 1 year of clinical research experience or relevant experience
1) Cover Letter
NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application
Depends on Qualifications
Scheduled Weekly Hours
Drug Test Required
Health Screen Required
Motor Vehicle Record Inquiry Required
Remove from Posting On or Before
The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, status as an individual with a disability, protected veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.
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.
The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: http://securityreport.uchicago.edu. Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.
- Posted 30+ Days Ago
- Full time