Clinical Research Nurse Coordinator

Clinical Research Nurse Coordinator

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.

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.

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.

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 problems.
• Interprets information from caregivers, nurses, or physicians about patient condition, treatment plans, or appropriate activities.
• Has a solid understanding of the information and techniques needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventive health-care measures.
• Performs other related work as needed.

Competencies:

• Research certification (e.g., SoCRA, ACRP, Graham School Clinical Trials Management & Regulatory Compliance).
• Fundamental working knowledge of clinical research.
• Knowledge of clinical trials regulatory requirements.
• Knowledge of patient care fundamentals, including aseptic principles and techniques.
• Ability to provide direct patient care in a professional and respectful manner.
• Ability to read medical documents and instruments.
• Ability to train junior research personnel.
• Ability to participate in protocol review and clinical trials evaluations.
• Excellent interpersonal skills.
• Excellent verbal and written communication.
• Strong data management skills and attention to detail.
• Excellent time management and ability to prioritize work assignments.
• Ability to read, understand, and implement clinical trials protocols.
• Working knowledge of Good Clinical Practices (GCP).
• Working knowledge of Microsoft Word, Excel and Adobe Acrobat.

Additional Responsibilities

Education:

• High School Diploma required.
• Bachelor's degree preferred.

Experience:

• Knowledge and skills developed through 2-5 years of work experience in a related job discipline required.
• 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.

Licenses and Certifications:

• Current valid Registered Nurse - Illinois license required.

Technical Knowledge or Skills:

• Demonstrated ability to access computer programs and use or learn basic computer operations.

Working Conditions and Physical Requirements:

• Office, clinic, and recruiting events.
• Occasional weekend/evening hours for enrollment events at community partner locations.
• Travel may be required for enrollment events at community partner locations.

Required Documents:

• Resume
• Cover Letter