University of Chicago · 6 hours ago
Clinical Research Coordinator II
Chicago, IL
Full-time
Onsite
Entry, Mid Level
$60K/yr - $75K/yr
2+ years expThe University of Chicago’s Respiratory Clinical Research team is seeking a Clinical Research Coordinator II (CRCII) to assist Principal Investigators in conducting various clinical trials and studies. The CRCII will manage daily clinical trial activities, ensuring compliance and supporting the administration of the study under limited supervision.
Higher Education
Responsibilities
Manages 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
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, coordinating reimbursement, and serving as the primary patient liaison for study-related inquiries and support while ensuring protocol adherence
Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules
Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures
Performs assessments at visits and monitors for adverse events
Organizes and attends site visits from sponsors and other relevant study meetings
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, 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 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
Works closely with Regulatory Manager to maintain accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, and study related communication
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
Accountable for all tasks in moderately complex clinical studies
Assists with various professional, organizational, and operational tasks under moderate supervision
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 2-5 years of work experience in a related job discipline
Resume (required)
Cover Letter (required)
Preferred
Bachelor's degree
Previous clinical research experience
Experience coordinating multiple studies (e.g., investigator initiated, industry sponsored, multi-site trials)
Knowledge of medical terminology/environment
Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others
Ability to communicate with tact and diplomacy
Strong organizational skills
Strong communication skills (verbal and written)
Excellent interpersonal skills
Strong data management skills and attention to detail
Knowledge of Microsoft Word, Excel and Adobe Acrobat
Ability to understand complex documents (e.g., clinical trials)
Ability to handle competing demands with diplomacy and enthusiasm
Ability to absorb large amounts of information quickly
Adaptability to changing working situations and work assignments
Benefits
The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and 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
University of Chicago has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
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Funding
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