Clinical Research Coordinator 2

University of Chicago; Chicago (IL); On-site; USD 65,000 - 85,000; Full time

Job summary

University of Chicago Comprehensive Cancer Center (UCCCC) seeks a Clinical Research Coordinator 2 (CRC2) to partner with the PI and manage daily trial activities under supervision. You will handle enrollment, data collection, and regulatory tasks, ensuring protocol adherence and patient safety.

You will coordinate visits, assist with informed consent, IRB submissions, and data integrity, supporting a high-volume trial program in the BSD. Strong communication with sponsors and staff is essential.

Qualifications

• Experience coordinating clinical trials and managing regulatory tasks.
• Ability to recruit and screen study participants under PI guidance.
• Familiarity with IRB processes and study start-up activities.

Responsibilities

• Manages all aspects of conducting clinical trials including screening, enrollment, follow-up, case report forms, and adverse event reports.
• Recruits and interviews potential study patients with guidance from PI and staff.
• Collects, processes, ships and stores specimens according to aseptic techniques.
• Coordinates study startup through closeout, including informed consent and protocol adherence.
• Ensures patient data confidentiality and compliance with regulations.

Skills

Clinical Research Coordination

Patient Recruitment

Regulatory Compliance

IRB Submissions

Data Management

Job description

Department

BSD CCC - Network Oncology Research Support

About the Department

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 independently 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 guidance 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 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 (CRF's), 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 sampleswith a limited to moderate degree of independence. Contributes to the problem solving on assigned clinical research studies and ta