Clinical Trials Nurse Leader

Biological Sciences Division at the University of Chicago; Chicago (IL); On-site; USD 70,000 - 95,000; Full time

Job summary

The University of Chicago IPPH in Chicago seeks a Clinical Research Nurse Coordinator to oversee and participate in daily activities of complex clinical trials. You will collaborate with the PI, APRNs, RM and investigators to ensure regulatory compliance and study readiness.

This at-will position may be funded by grant funds and will involve leading research staff, coordinating study procedures, and maintaining thorough regulatory documentation, with emphasis on quality and patient safety.

Qualifications

• 2-5 years of experience in a related job discipline.
• Nursing experience in an acute care or ambulatory setting preferred.
• Phlebotomy and/or intravenous line placement experience preferred.
• Clinical research experience preferred.
• Experience with Epic or other electronic medical records preferred.

Responsibilities

• Coordinate and participate in the conduct of clinical research trials at the Institute for Population and Precision Health (IPPH).
• Assist with or plan and implement the clinical study's goals and objectives; organize patient enrollment planning; conduct quality assurance activities, compile and analyze data.
• Develop and implement study procedures, maintains study records, tracks study progress, and conducts quality assurance on study data collected.
• Prepare, submit, and assist investigators with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
• Provide direct supervision of other research staff (i.e. hiring/firing, performance evaluations, disciplinary actions, approve time off, etc.), or assist.
• Act as a liaison with medical staff, university departments, ancillary departments and/or satellite facilities.
• Conduct clinical study tasks including physical assessment of subjects, taking vital signs, recording medical, surgical, social and behavioral histories, and phlebotomy skills.
• Serve as a resource person or act as a consultant within area of clinical expertise.
• Act as a leader within the department/unit through improving clinical research practice and serving as a resource.
• Maintain working knowledge of current protocols, and internal SOPs.
• Be accountable for high standards of clinical research practice and assist in the development of accountability in others.
• Oversee and participate in the coordination and conduct of complex clinical research studies and ensure compliance with study standard operating protocols and procedures as well as federal and institutional regulations.
• Provide Investigators with guidance regarding protocol requirements.
• Maintain regulatory documentation.
• Assist other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety Review Committee.
• Prepare for and assist with audits, inspections, and monitoring visits from regulatory agencies or sponsors.

Skills

Clinical research

Regulatory compliance

Data management

Communication skills

Education

Bachelor's degree preferred

Tools

Epic EMR

MS Word

MS Excel

Adobe Acrobat

Job description

The University of Chicago IPPH in Chicago seeks a Clinical Research Nurse Coordinator to oversee and participate in daily activities of complex clinical trials. You will collaborate with the PI, APRNs, RM and investigators to ensure regulatory compliance and study readiness.

This at-will position may be funded by grant funds and will involve leading research staff, coordinating study procedures, and maintaining thorough regulatory documentation, with emphasis on quality and patient safety.