BSD PED - Clinical Trials Office: COG and HemOnc Research
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.
Job Summary
The Clinical Research Coordinator 1 provides support to the Investigator Initiated Trial for Solid Tumors within the Section of Hematology/Oncology within the Department of Pediatrics. The CRC will be involved in coordinating all aspects of the study under the supervision of the PI. The Clinical Research Coordinator 1 works under the general direction of the PI and leadership within the Pediatric Clinical Trials Office.
Our department follows a hybrid work structure that fosters productivity, collaboration, and employee well-being. Working from the office is encouraged for tasks that require a high degree of collaboration.
Responsibilities
Coordinates all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
Recruit and interview potential study patients with guidance from PI and other clinical research staff.
Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.
Maintains accurate and complete documentation of signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.
Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.
Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.
Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and potential side effects.
Organizes and attends site visits from sponsors and other relevant study meetings.
Identify and explain the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.
Coordinate the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.
Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.
Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.
Understand 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.
Ensures compliance with federal regulations and institutional policies.
Prepares for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
Participates in 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 Qualifications
Education:
Minimum requirements include vocational training, apprenticeships or the equivalent experience in related field (not typically required to have a four-year degree).
--- Work Experience:
Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.
--- Certifications:
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Preferred Qualifications
Education:
Bachelor's Degree.
Experience:
Clinical research experience or relevant experience.
Preferred Competencies
Ability to communicate in writing.
Ability to communicate orally.
Ability to develop and manage interpersonal relationships.
Ability to exercise absolute discretion regarding confidential matters.
Ability to follow written and/or verbal instructions.
Ability to handle sensitive matters with tact and discretion.
Ability to handle stressful situations.
Ability to learn and develop skills.
Ability to pay attention to detail.
Ability to perform multiple tasks simultaneously.
Ability to prioritize work and meet deadlines.
Ability to work effectively and collegially with little supervision or as member of a team.
Ability to work independently.
Strong data management skills and attention to detail.
Knowledge of Microsoft Word, Excel and Adobe Acrobat.
Knowledge of data analysis.
Ability to work with Redcap.
Ability to read and understand complex documents (e.g., clinical trials).
Ability to handle competing demands with diplomacy and enthusiasm.
Ability to absorb large amounts of information quickly.
Ability to work effectively and collegially with little supervision or as member of a team.
Ability to work independently.
Working Conditions
Eligible for hybrid work based on business needs and the demands of specific tasks. Working from the office is encouraged for tasks that require a high degree of collaboration.
Application Documents
Resume (required)
Cover Letter (required)
When applying, the document(s) MUSTbe uploaded via the My Experience page, in the section titled Application Documents of the application.
Job Family
Research
Role Impact
Individual Contributor
FLSA Status
Non-Exempt
Pay Frequency
Biweekly
Scheduled Weekly Hours
40
Benefits Eligible
Yes
Drug Test Required
Yes
Health Screen Required
Yes
Motor Vehicle Record Inquiry Required
No
Posting Statement
The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, national or ethnic origin, age, status as an individual with a disability, military or 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.
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.
All offers of employment are contingent upon a background check that includes a review of conviction history. A conviction does not automatically preclude University employment. Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.
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