The University of Chicago
Clinical Research Coordinator 2
The University of Chicago, Orland Park, Illinois, United States, 60467
Job Summary
The Clinical Research Coordinator 2 (CRC2) is a specialized researcher partnering with the clinical Principal Investigator (PI) and under the direction of a departmental or lab research manager. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC2 supports, facilitates, and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties with limited supervision and/or guidance, the CRC2 works with the PI, department, sponsor, and institution to support and provide advice on the administration of the compliance, financial, personnel, and other related aspects of the clinical study.
Responsibilities
Manages all aspects of conducting clinical trials, including screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
Recruits and interviews potential study patients with guidance from PI and other clinical research staff.
Collects, processes, ships, and stores specimens to the appropriate laboratory according to established aseptic techniques.
Identifies and explains the responsibilities of principal investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.
Coordinates 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.
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.
Protects 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.
Maintains accurate and complete records which may include informed consent, IRB approvals, source documentation, Case Report Forms (CRFs), drug dispensing logs, and study-related communications.
Understands the IRB submission and review process and when/how to apply for IRB review, including preparation of IRB submissions independently.
Ensures compliance with federal regulations and institutional policies.
May prepare and maintain protocol submissions and revisions.
May assist in the training of new or backup coordinators.
Assists with various professional, organizational, and operational tasks under moderate supervision.
Facilitates and participates in the daily activities of moderately complex clinical studies and performs activities including patient data retrieval, documenting clinical research records, and participation in program audits.
Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with limited to moderate independence. Contributes to problem solving on assigned clinical research studies and tasks.
Performs other related work as needed.
Minimum Qualifications Education:
A college or university degree in a related field.
Work Experience:
2-5 years of work experience in a related job discipline.
Certifications:
---
Preferred Qualifications Education:
Bachelor's degree.
Relevant clinical research experience.
Working knowledge of coordinating multiple studies (e.g., investigator-initiated, industry-sponsored, multi-site trials).
Preferred Competencies
Ability to interact with clarity, tact, and courtesy with patients, staff, faculty, students, and others.
Strong organizational skills.
Excellent interpersonal skills.
Strong data management skills and attention to detail.
Expert knowledge of the Microsoft suite, including Outlook.
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.
Working Conditions
Ability to navigate the assigned UChicago location as required by the position.
Hybrid work arrangements may be considered.
Application Documents
Resume (required)
Cover letter (preferred)
When applying, the document(s) must be uploaded via the My Experience page, in the section titled Application Documents of the application.
Other 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 Rate Type: Salary
FLSA Status: Exempt
Pay Range: $60,000.00 - $75,000.00
Benefits Eligible: Yes
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, age, 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.
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 and is considered on a case-by-case basis.
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The Clinical Research Coordinator 2 (CRC2) is a specialized researcher partnering with the clinical Principal Investigator (PI) and under the direction of a departmental or lab research manager. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC2 supports, facilitates, and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties with limited supervision and/or guidance, the CRC2 works with the PI, department, sponsor, and institution to support and provide advice on the administration of the compliance, financial, personnel, and other related aspects of the clinical study.
Responsibilities
Manages all aspects of conducting clinical trials, including screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
Recruits and interviews potential study patients with guidance from PI and other clinical research staff.
Collects, processes, ships, and stores specimens to the appropriate laboratory according to established aseptic techniques.
Identifies and explains the responsibilities of principal investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.
Coordinates 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.
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.
Protects 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.
Maintains accurate and complete records which may include informed consent, IRB approvals, source documentation, Case Report Forms (CRFs), drug dispensing logs, and study-related communications.
Understands the IRB submission and review process and when/how to apply for IRB review, including preparation of IRB submissions independently.
Ensures compliance with federal regulations and institutional policies.
May prepare and maintain protocol submissions and revisions.
May assist in the training of new or backup coordinators.
Assists with various professional, organizational, and operational tasks under moderate supervision.
Facilitates and participates in the daily activities of moderately complex clinical studies and performs activities including patient data retrieval, documenting clinical research records, and participation in program audits.
Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with limited to moderate independence. Contributes to problem solving on assigned clinical research studies and tasks.
Performs other related work as needed.
Minimum Qualifications Education:
A college or university degree in a related field.
Work Experience:
2-5 years of work experience in a related job discipline.
Certifications:
---
Preferred Qualifications Education:
Bachelor's degree.
Relevant clinical research experience.
Working knowledge of coordinating multiple studies (e.g., investigator-initiated, industry-sponsored, multi-site trials).
Preferred Competencies
Ability to interact with clarity, tact, and courtesy with patients, staff, faculty, students, and others.
Strong organizational skills.
Excellent interpersonal skills.
Strong data management skills and attention to detail.
Expert knowledge of the Microsoft suite, including Outlook.
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.
Working Conditions
Ability to navigate the assigned UChicago location as required by the position.
Hybrid work arrangements may be considered.
Application Documents
Resume (required)
Cover letter (preferred)
When applying, the document(s) must be uploaded via the My Experience page, in the section titled Application Documents of the application.
Other 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 Rate Type: Salary
FLSA Status: Exempt
Pay Range: $60,000.00 - $75,000.00
Benefits Eligible: Yes
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, age, 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.
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 and is considered on a case-by-case basis.
#J-18808-Ljbffr