University of Chicago · 7 hours ago
Senior Clinical Research Coordinator 2
Chicago, IL
Full-time
Onsite
Senior Level
$75K/yr - $90K/yr
5+ years expThe University of Chicago is a prestigious institution dedicated to advancing complex pediatric care and research. They are seeking a Senior Clinical Research Coordinator 2 to manage high complexity clinical studies, oversee research staff, and ensure compliance with regulations while supporting various clinical trials in the Department of Pediatrics.
Higher Education
Responsibilities
Manages high complexity clinical studies and owns administrative tasks. Assists with strategic planning for the research department. Trains lower-level roles
Studies have high complexity with limited oversight
Manages all aspects of conducting clinical trials including screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports. Acts as a liaison with medical staff, University departments, ancillary departments and/or satellite facilities
Acts as a leader within the department/unit through improving clinical research practice and serving as a resource
Maintains working knowledge of current protocols and internal SOPs
Accountable for high standards of clinical research practice and assists in the development of accountability in others
Develops and implements procedures, maintains records, tracks progress, and conducts quality assurance on data collected
Oversees and participates in the coordination and conduct of complex clinical research studies and ensures compliance with federal and institutional regulations
Prepares, submits, and assists investigators with multiple levels of research documentation, such as IRB submissions, educational materials, reports, grant renewal reports, and study forms
Provides investigators with guidance regarding protocol requirements
Maintains regulatory documentation
Assists other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety Review Committee
Provides direct supervision of other clinical research staff, such as hiring/firing, performance evaluations, disciplinary actions, approve time off, etc., or assistance
Attends continuing education and training opportunities relevant to job duties
Analyzes, facilitates and participates in the daily activities of multiple moderately complex clinical trials and performs all aspects of clinical data management, including patient data retrieval, referring MD office records, preparing clinical research charts, and participation in program audits
Prepares program conference lists for multidisciplinary conferences and workshops. Participates in all pharmaceutical site visits. Uses moderate understanding of clinical trials to collect and store patient specimens, radiology scans and reports
Solves a range of complex problems relating to the administration of the compliance, financial and other related aspects of a clinical study
Performs various professional, organizational, and operational tasks under limited supervision. Acts as a resource on clinical research and related aspects of clinical study for other clinical research staff. Accountable for complex problem solving on assigned clinical research studies and professional tasks
Facilitates and participates in the daily activities of complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits. Uses in-depth knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a high degree of independence
Performs other related work as needed
Qualification
Required
Minimum requirements include a college or university degree in related field
Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a related job discipline
Manages high complexity clinical studies and owns administrative tasks
Studies have high complexity with limited oversight
Manages all aspects of conducting clinical trials including screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports
Acts as a liaison with medical staff, University departments, ancillary departments and/or satellite facilities
Acts as a leader within the department/unit through improving clinical research practice and serving as a resource
Maintains working knowledge of current protocols and internal SOPs
Accountable for high standards of clinical research practice and assists in the development of accountability in others
Develops and implements procedures, maintains records, tracks progress, and conducts quality assurance on data collected
Oversees and participates in the coordination and conduct of complex clinical research studies and ensures compliance with federal and institutional regulations
Prepares, submits, and assists investigators with multiple levels of research documentation, such as IRB submissions, educational materials, reports, grant renewal reports, and study forms
Provides investigators with guidance regarding protocol requirements
Maintains regulatory documentation
Assists other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety Review Committee
Provides direct supervision of other clinical research staff, such as hiring/firing, performance evaluations, disciplinary actions, approve time off, etc., or assistance
Attends continuing education and training opportunities relevant to job duties
Analyzes, facilitates and participates in the daily activities of multiple moderately complex clinical trials and performs all aspects of clinical data management, including patient data retrieval, referring MD office records, preparing clinical research charts, and participation in program audits
Prepares program conference lists for multidisciplinary conferences and workshops
Participates in all pharmaceutical site visits
Uses moderate understanding of clinical trials to collect and store patient specimens, radiology scans and reports
Solves a range of complex problems relating to the administration of the compliance, financial and other related aspects of a clinical study
Performs various professional, organizational, and operational tasks under limited supervision
Acts as a resource on clinical research and related aspects of clinical study for other clinical research staff
Accountable for complex problem solving on assigned clinical research studies and professional tasks
Facilitates and participates in the daily activities of complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits
Uses in-depth knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a high degree of independence
Performs other related work as needed
Preferred
Bachelor's degree
5 years of clinical research experience coordinating multiple and variety of studies, such as investigator initiated; industry sponsored; multi-site trials
Overseeing staff
Read and understand clinical trials protocols
Familiarity with medical terminology/environment
Working knowledge of good clinical practices (GCP)
Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat
Comprehend technical documents
Understanding of the federal research regulations and identify the federal research organizations' role in regulating human research participation
Train junior CRCs; train or teach others
Participate in protocol review and clinical trials evaluations
Excellent interpersonal skills
Strong data management skills and attention to detail
Handle competing demands with diplomacy and enthusiasm
Work collaboratively with faculty and divisional clinical research infrastructure
Excellent time management and prioritize work assignments
Communicate in writing
Communicate orally
Develop and manage interpersonal relationships
Exercise absolute discretion regarding confidential matters
Follow written and/or verbal instructions
Give directions
Handle sensitive matters with tact and discretion
Handle stressful situations
Learn and develop skills
Maintain a high level of alertness
Pay attention to detail
Perform multiple tasks simultaneously
Prioritize work and meet deadlines
React effectively, quickly, calmly, and rationally during conflicts and emergencies
Work effectively and collegially with little supervision or as member of a team
Work independently
Benefits
Health
Retirement
Paid time off
Company
University of Chicago
One of the world’s great intellectual destinations, the University of Chicago empowers scholars and students to ask tough questions, cross disciplinary boundaries, and challenge conventional thinking to enrich human life around the globe.
10001+ employees
H1B Sponsorship
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