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 and works under the direction of a departmental or laboratory research manager. The CRC2 independently supports, facilitates, and coordinates daily clinical trial activities with limited supervision or guidance. The role works with the PI, department, sponsor, and institution on compliance, financial, personnel, and other administrative aspects of clinical studies. The CRC2 coordinates multiple moderately complex clinical trials from startup through closeout, including subject recruitment and screening, informed consent, study visits and treatment schedules, data collection, protocol adherence, safety monitoring, and study records. The position also supports regulatory submissions, audits, site visits, and training of new or backup coordinators.

Requirements

College or university degree in a related field.
Two to five years of work experience in a related job discipline.
Ability to communicate in writing and orally.
Ability to condense complicated issues into clear summaries for varied audiences.
Ability to develop and manage interpersonal relationships and work effectively with little supervision or as part of a team.
Ability to work independently, follow instructions, give directions, and train or teach others.
Exercise discretion with confidential matters and handle sensitive matters with tact.
Ability to handle stressful situations and respond effectively, quickly, calmly, and rationally during conflicts and emergencies.
Ability to learn and develop skills, maintain alertness, and pay attention to detail.
Ability to perform multiple tasks simultaneously, prioritize work, and meet deadlines.

Nice To Haves

Bachelor’s degree.
Clinical research or 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 forms, and adverse event reports.
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 roles and responsibilities of investigators, research team members, sponsors, CROs, and regulatory authorities in clinical trials.
Coordinate studies from startup through closeout, including recruitment, 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 risks and benefits.
Perform visit assessments and monitor for adverse events.
Organize and attend sponsor site visits and other relevant study meetings.
Protect patient and data confidentiality and ensure the security of research data and personal health information.
Implement and document SOPs according to sponsor, PI, and regulatory agency requirements.
Maintain complete and accurate study records, including consent forms, IRB approvals, source documentation, CRFs, drug dispensing logs, and study communications.
Prepare timely IRB submissions independently and understand the IRB submission and review process.
Ensure compliance with federal regulations and institutional policies; may prepare and maintain protocol submissions and revisions.
Assist in training new or backup coordinators.
Coordinate daily activities of multiple moderately complex clinical trials and perform clinical data management, including patient data retrieval, obtaining referring physician office records, preparing research charts, and participating in program audits.
Resolve straightforward issues related to compliance, financial, and other administrative aspects of clinical studies.
Take accountability for all tasks in moderately complex clinical studies.
Perform other related work as needed.