University of Chicago
Clinical Research Coordinator 1 – Pediatrics
University of Chicago, Chicago, Illinois, United States, 60290
Overview
Department: BSD PED - Clinical Trials Office. The Department of Pediatrics at the University of Chicago is a dynamic place to work focused on complex pediatric care, education and training, and impactful scholarship. The department collaborates with UChicago Medicine Comer Children’s Hospital and regional sites across Northern Illinois and Northwestern Indiana, with the Chicagoland Children’s Health Alliance (CCHA) to extend care to nearly 1 million children. Our mission emphasizes family-centered care, clinical excellence, impactful scholarship, disease prevention, and advocating for every child.
The Pediatric Clinical Trials Office (Peds CTO) provides centralized support, standards, SOPs, policies, educational programs, and administrative functions for individuals involved in human subjects research at the University and Hospital.
Job Summary The Clinical Research Coordinator (CRC) 1 in Pediatrics provides support to the section of Infectious Disease within the Department of Pediatrics. The CRC works under the direction of the Director of Clinical Research, the PI, and the study team. The CRC will be involved in multiple research trial types, including multi-centered cooperative group and intergroup studies at a national level, multi-institutional pharmaceutical trials, and multi-centered trials designed and coordinated in the Section, with primary responsibility coordinating vaccine clinical trials.
Responsibilities
Aliquot and prepare experimental and clinical samples for freezing.
Ensure accurate storage for all specimen types, including blood and plasma samples.
Coordinate 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 the PI and other clinical research staff.
Maintain accurate and complete documentation of signed informed consent, IRB approvals, source documentation, Case Report Forms (CRFs), and study-related communication.
Plan and coordinate patient schedules for study procedures, return visits, and study treatment schedules.
Perform experiments; collect, analyze, and interpret data under the supervision of the PI or designee.
Ensure SOPs are implemented and documented per sponsor, PI, and regulatory specifications.
Educate patients about study procedures, visit schedules, reporting expectations, and potential side effects.
Protect patient and data confidentiality by ensuring security of research data and PHI and compliance with federal regulations and sponsor protocols.
Understand IRB submission and review processes and facilitate study initiation through timely preparation of IRB submissions.
Coordinate study conduct from startup through closeout, including recruitment and screening, informed consent, data collection, and protocol adherence.
Assist with preparation and attendance at intervention sessions.
Ensure compliance with federal regulations and institutional policies.
Prepare for or participate in quality assurance audits conducted by sponsors, federal agencies, or designated review groups.
Participate in study-related documentation such as protocol worksheets, manuals, adverse event reports, IRB documents, and progress reports.
Educate patients about study procedures, risks and benefits, and report expectations.
Perform assessments at visits and monitor for adverse events.
Organize and attend site visits from sponsors and study meetings.
May prepare and maintain protocol submissions and revisions.
May assist in training of new or backup coordinators.
Collect and process specimens, interview subjects, take vital signs, and contribute to the case report.
Analyze study-related documentation and ensure data quality.
Remain accountable for tasks in basic clinical studies and support other tasks under supervision.
Use knowledge of clinical studies to coordinate collection of analyzable data and/or samples.
Perform other related work as needed.
Education and Qualifications Minimum Qualifications
Minimum requirements include a college or university degree in a related field.
Work Experience
Minimum requirements include knowledge and skills developed through less than 2 years of work experience in a related job discipline.
Certifications
Preferred Qualifications:
Education
Bachelor’s degree (preferred).
Experience
1 year of clinical research experience or relevant experience.
Technical Skills or Knowledge
Knowledge of Microsoft Word, Excel, and Adobe Acrobat.
Ability to read and understand complex documents (e.g., clinical trials).
Preferred Competencies
Written and oral communication skills.
Interpersonal relationship development and discretion with confidential matters.
Ability to follow written and/or verbal instructions.
Handling sensitive matters with tact and discretion; managing stress; attention to detail.
Ability to learn and develop new skills; multi-tasking; prioritization and meeting deadlines.
Teamwork and independent work capability; strong data management skills.
Application Documents
Resume/CV (required)
Cover Letter (required)
When applying, upload documents via the My Experience page, in the Application Documents section of the application.
Additional Details
Job Family: Research
Role Impact: Individual Contributor
Scheduled Weekly Hours: 40
Drug Test Required: Yes
Health Screen Required: Yes
Motor Vehicle Record Inquiry Required: No
Pay Type: Salary
FLSA Status: Exempt
Pay Range: $50,000.00 - $65,000.00
The included pay rate or range represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting.
Benefits and Posting Statement Benefits Eligible: Yes. The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information is available in the Benefits Guidebook.
Posting Statement: The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, ancestry, age, disability, military or veteran status, genetic information, or other protected classes. For more information, see the University’s Notice of Nondiscrimination. Reasonable accommodation requests can be made by calling 773-702-5800 or via the Applicant Inquiry Form.
All offers of employment are contingent upon a background check that includes a review of conviction history. A conviction does not automatically preclude employment; it is considered on a case-by-case basis.
The University of Chicago’s Annual Security & Fire Safety Report is available online at securityreport.uchicago.edu. Paper copies are available on request from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.
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The Pediatric Clinical Trials Office (Peds CTO) provides centralized support, standards, SOPs, policies, educational programs, and administrative functions for individuals involved in human subjects research at the University and Hospital.
Job Summary The Clinical Research Coordinator (CRC) 1 in Pediatrics provides support to the section of Infectious Disease within the Department of Pediatrics. The CRC works under the direction of the Director of Clinical Research, the PI, and the study team. The CRC will be involved in multiple research trial types, including multi-centered cooperative group and intergroup studies at a national level, multi-institutional pharmaceutical trials, and multi-centered trials designed and coordinated in the Section, with primary responsibility coordinating vaccine clinical trials.
Responsibilities
Aliquot and prepare experimental and clinical samples for freezing.
Ensure accurate storage for all specimen types, including blood and plasma samples.
Coordinate 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 the PI and other clinical research staff.
Maintain accurate and complete documentation of signed informed consent, IRB approvals, source documentation, Case Report Forms (CRFs), and study-related communication.
Plan and coordinate patient schedules for study procedures, return visits, and study treatment schedules.
Perform experiments; collect, analyze, and interpret data under the supervision of the PI or designee.
Ensure SOPs are implemented and documented per sponsor, PI, and regulatory specifications.
Educate patients about study procedures, visit schedules, reporting expectations, and potential side effects.
Protect patient and data confidentiality by ensuring security of research data and PHI and compliance with federal regulations and sponsor protocols.
Understand IRB submission and review processes and facilitate study initiation through timely preparation of IRB submissions.
Coordinate study conduct from startup through closeout, including recruitment and screening, informed consent, data collection, and protocol adherence.
Assist with preparation and attendance at intervention sessions.
Ensure compliance with federal regulations and institutional policies.
Prepare for or participate in quality assurance audits conducted by sponsors, federal agencies, or designated review groups.
Participate in study-related documentation such as protocol worksheets, manuals, adverse event reports, IRB documents, and progress reports.
Educate patients about study procedures, risks and benefits, and report expectations.
Perform assessments at visits and monitor for adverse events.
Organize and attend site visits from sponsors and study meetings.
May prepare and maintain protocol submissions and revisions.
May assist in training of new or backup coordinators.
Collect and process specimens, interview subjects, take vital signs, and contribute to the case report.
Analyze study-related documentation and ensure data quality.
Remain accountable for tasks in basic clinical studies and support other tasks under supervision.
Use knowledge of clinical studies to coordinate collection of analyzable data and/or samples.
Perform other related work as needed.
Education and Qualifications Minimum Qualifications
Minimum requirements include a college or university degree in a related field.
Work Experience
Minimum requirements include knowledge and skills developed through less than 2 years of work experience in a related job discipline.
Certifications
Preferred Qualifications:
Education
Bachelor’s degree (preferred).
Experience
1 year of clinical research experience or relevant experience.
Technical Skills or Knowledge
Knowledge of Microsoft Word, Excel, and Adobe Acrobat.
Ability to read and understand complex documents (e.g., clinical trials).
Preferred Competencies
Written and oral communication skills.
Interpersonal relationship development and discretion with confidential matters.
Ability to follow written and/or verbal instructions.
Handling sensitive matters with tact and discretion; managing stress; attention to detail.
Ability to learn and develop new skills; multi-tasking; prioritization and meeting deadlines.
Teamwork and independent work capability; strong data management skills.
Application Documents
Resume/CV (required)
Cover Letter (required)
When applying, upload documents via the My Experience page, in the Application Documents section of the application.
Additional Details
Job Family: Research
Role Impact: Individual Contributor
Scheduled Weekly Hours: 40
Drug Test Required: Yes
Health Screen Required: Yes
Motor Vehicle Record Inquiry Required: No
Pay Type: Salary
FLSA Status: Exempt
Pay Range: $50,000.00 - $65,000.00
The included pay rate or range represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting.
Benefits and Posting Statement Benefits Eligible: Yes. The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information is available in the Benefits Guidebook.
Posting Statement: The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, ancestry, age, disability, military or veteran status, genetic information, or other protected classes. For more information, see the University’s Notice of Nondiscrimination. Reasonable accommodation requests can be made by calling 773-702-5800 or via the Applicant Inquiry Form.
All offers of employment are contingent upon a background check that includes a review of conviction history. A conviction does not automatically preclude employment; it is considered on a case-by-case basis.
The University of Chicago’s Annual Security & Fire Safety Report is available online at securityreport.uchicago.edu. Paper copies are available on request from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.
#J-18808-Ljbffr