Temporary Clinical Research Nurse Coordinator, Clinical Trials

Department

BSD IPP–NPH

About the Department

The Institute for Population and Precision Health (IPPH), located in the Biological Sciences Division, integrates a wide spectrum of factors such as human health behaviors, environmental factors, social and economic factors, policies and genetic determinants of health, into studies focused on the treatment and prevention of disease, as well as the maintenance of wellness. Leveraging and integrating the University of Chicago’s considerable institutional strength in population science with research spanning diverse fields such as genetic medicine, cancer epidemiology, microbiome, and epigenomics, the Institute will have the common goal of improving human health outcomes. Another major goal of the Institute will be to develop a new multidisciplinary training program to equip researchers with emerging tools and methods to conduct precision health research within a population health framework. Our faculty lead research projects in biostatistics, epidemiology and health services research and participate in interdisciplinary teams with faculty in other departments to address complex problems in health and healthcare, in our communities and around the globe.
This at-will position is wholly or partially funded by contractual grant funding which is renewed under provisions set by the grantor of the contract. Employment will be contingent upon the continued receipt of these grant funds and satisfactory job performance.

Job Information

Job Summary:

While the Principal Investigator (PI) is primarily responsible for the overall design, conduct, and management of clinical trials.  Under the direction of the PI, Co-Investigators, Advanced Practice Registered Nurses (APRNs) and Research Manager (RM), the Clinical Research Nurse Coordinator oversees, facilitates, and participates in the conduct of daily activities of complex clinical trials and plays a critical role in the conduct of the studies to ensure compliance with federal and institutional regulations. The Clinical Research Nurse Coordinator acts as a leader within the department/unit through improving clinical research practice and serves as a resource to others. By performing these duties, the Clinical Research Nurse Coordinator 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 studies.

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.

• Applies logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to proble