Clinical Research Coordinator 2 - Hematology/Oncology

University of Chicago•Hyde Park, IL

About The Position

The Clinical Research Coordinator 2 (CRC2) is a specialized researcher who partners with the clinical Principal Investigator (PI) and works under the direction of a departmental or lab research manager. The PI is primarily responsible for the overall design, conduct, and management of the clinical trial, while the CRC2 independently supports, facilitates, and coordinates daily trial activities. With limited supervision or guidance, the CRC2 works with the PI, department, sponsor, and institution on compliance, financial, personnel, and other administrative aspects of clinical studies. The position supports clinical research in the Section of Hematology/Oncology, a program focused on research-based patient care and clinical discovery across malignancies, blood disorders, and experimental therapies. The CRC2 coordinates moderately complex clinical studies from startup through closeout, conducts clinical data management, maintains regulatory and study documentation, and helps ensure adherence to protocols and applicable regulations. The role may also assist with training new or backup coordinators and perform other related work as needed.

Requirements

College or university degree in a related field.
2–5 years of work experience in a related job discipline.
Ability to communicate in writing and orally.
Ability to condense complicated issues into summaries understandable to varied constituents.
Ability to develop and manage interpersonal relationships.
Exercise discretion with confidential matters and handle sensitive matters tactfully.
Follow written and verbal instructions and give directions.
Handle stressful situations and respond effectively, quickly, calmly, and rationally during conflicts and emergencies.
Learn and develop skills, maintain alertness, and pay attention to detail.
Perform multiple tasks simultaneously, prioritize work, and meet deadlines.
Train or teach others.
Work effectively and collegially with little supervision or as part of a team, and work independently.

Nice To Haves

Bachelor’s degree.
Clinical research or other relevant experience.
Experience coordinating multiple studies, including investigator-initiated, industry-sponsored, and multisite trials.
Awareness of safety hazards and appropriate precautions.
Ability to comprehend technical documents and create and deliver presentations.

Responsibilities

Manage clinical trial activities including screening, enrollment, subject follow-up, case report form completion, and adverse event reporting.
Recruit and interview potential study patients with guidance from the PI and other clinical research staff.
Collect, process, ship, and store specimens according to established aseptic techniques and laboratory requirements.
Explain the responsibilities of PIs, research team members, sponsors, CROs, and regulatory authorities in clinical trials.
Coordinate studies from startup through closeout, including recruitment and screening, informed consent, research data collection, and protocol adherence.
Plan patient schedules for study procedures, return visits, and treatment schedules.
Educate patients about study procedures, visit schedules, what to report, and procedure risks and benefits.
Perform visit assessments and monitor for adverse events.
Organize and attend sponsor site visits and relevant study meetings.
Protect patient and data confidentiality and ensure security of research data and personal health information in accordance with federal regulations and sponsor protocols.
Implement and document SOPs according to sponsor, PI, and regulatory agency requirements.
Maintain complete and accurate study records, including informed consents, IRB approvals, source documentation, CRFs, drug dispensing logs, and study communications.
Understand the IRB submission and review process and independently prepare timely, thorough submissions to facilitate study initiation.
Ensure compliance with federal regulations and institutional policies; prepare and maintain protocol submissions and revisions as needed.
Assist in training new or backup coordinators.
Coordinate multiple moderately complex clinical trials and conduct clinical data management, including retrieving patient data and referring physician office records, preparing research charts, and participating in program audits.
Address straightforward compliance, financial, and other administrative issues related to clinical studies.
Document clinical research records and participate in program audits.
Be accountable for all tasks in moderately complex clinical studies.
Perform other related work as needed.