Clinical Research Coordinator 2
Department
BSD CCC - Network Oncology Research Support
About the Department
About the Unit
The University of Chicago Comprehensive Cancer Center (UCCCC) is an integral component of the Biological Sciences Division (BSD). The BSD is the largest of four Divisions of the University and includes the Pritzker School of Medicine. UCCCC administers four established scientific programs, and the NCI-sponsored Cancer Center Support Grant funds ten Shared Resources. The Comprehensive Cancer Center comprises over 190 faculty members from twenty departments, with members currently being awarded over $47 million in total direct costs in peer-reviewed cancer research grants, and $28 million in non-peer-reviewed grants and contracts. The activities of the Center are broad and varied, including research, training and education, communications, fundraising, marketing, clinical trials management, and community outreach.
UCCCC has one of the largest cancer clinical trials programs in the country and in the Chicago area, with nearly 500 adult and pediatric therapeutic trials actively accruing patients. Many of these studies are investigator-initiated, including Phase I or I/II trials, demonstrating UCCCC's commitment to translating basic research findings to the clinic through proof-of-principle and early-phase studies. UCCCC opens over 250 new trials each year and accrues approximately 900 participants to therapeutic trials each year.
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, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRFs), drug dispensing logs, and study-related communication.
- Understands 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.
- 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 various 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 a limited to moderate degree of independence. Contributes to the problem solving on assigned clinical research studies and tasks.
- Performs other related work as needed.
Minimum Qualifications
Education:
Minimum requirements include a college or university degree in related field.
Work Experience:
Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.
Certifications:
---
Preferred Qualifications
Education:
- Bachelor's degree.
Experience:
- Relevant clinical research experience.
- Working knowledge of coordinating multiple studies (e.g., investigator-initiated, industry-sponsored, multi-site trials).
Preferred Competencies
- Ability to interact and communicate with clarity, tact, and courtesy with patrons, 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.
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
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 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 about the benefit offerings can be found 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, shared ancestry, 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.
Job seekers in need of a reasonable accommodation to complete the application process should call [click to reveal phone number] or submit a request via 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 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.
The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: [click to reveal website link]. Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.