Clinical Research Coordinator 1 (Project -Based, 18 month) - JR26209-3800

University of Chicago - Chicago, IL

Full-time - Entry Level

Chicago, IL

Educational Services

About the position

The Clinical Research Coordinator 1 (CRC1) position at the University of Chicago Comprehensive Cancer Center (UCCCC) is a project-based role expected to last for 18 months. This specialized researcher will work closely with the clinical Principal Investigator (PI) and under the guidance of a departmental or lab research manager. The CRC1 plays a critical role in supporting, facilitating, and coordinating the daily activities of clinical trials, ensuring that the studies are conducted efficiently and in compliance with all regulations. While the PI is responsible for the overall design and management of the clinical trial, the CRC1 will independently manage various aspects of the trial, including documentation, analysis, and reporting of research data. The UCCCC is a prominent institution within the Biological Sciences Division (BSD) of the University of Chicago, known for its extensive cancer clinical trials program. With nearly 500 active therapeutic trials, the center is committed to translating basic research findings into clinical applications. The CRC1 will be involved in a range of activities, from recruiting and interviewing potential study patients to ensuring adherence to study protocols and maintaining accurate records. This position is contingent upon the continued receipt of grant funding and satisfactory job performance, highlighting the importance of effective project management and compliance in clinical research. In this role, the CRC1 will also be responsible for educating patients about study procedures, monitoring for adverse events, and ensuring the confidentiality of patient data. The position requires a thorough understanding of the IRB submission process and compliance with federal regulations, making it essential for the CRC1 to be detail-oriented and proactive in managing clinical trial activities.

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 (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.

Requirements

• Bachelor's degree in a related field or equivalent experience in clinical research.
• Experience in clinical research or a related field is preferred.
• Strong organizational skills and attention to detail.
• Ability to work independently and as part of a team.
• Excellent communication and interpersonal skills.

Nice-to-haves

• Experience with IRB submissions and regulatory compliance.
• Familiarity with clinical trial management software.
• Knowledge of Good Clinical Practice (GCP) guidelines.

Benefits

• Health insurance coverage
• Dental insurance coverage
• 401k retirement savings plan
• Paid holidays
• Flexible scheduling options