At the PI's direction, the Clinical Research Nurse 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 acts as a leader within the department/unit by improving clinical research practice and serving others.
By performing these duties, the Clinical Research Nurse works with the PI, department, sponsor, and institution to support and provide guidance on administering the clinical studies.
Oversee and participate in the coordination and conduct of complex clinical research studies and ensure compliance with federal and institutional regulations.
Assist with, plan and implement the clinical study's goals and objectives; organize patient screening, intake, and enrollment; conduct quality assurance activities; compile and analyze data.
Maintain working knowledge of current protocols and internal SOPs.
Orders and assures scheduling of all tests required for entry into the protocol. Assures that the results meet protocol-specific criteria before patient enrollment.
Be accountable for high standards of clinical research practice and assist in the development of accountability in others.
Develop and implement procedures, maintain records, track progress, and conduct quality assurance on data collected.
Prepare, submit, and assist Investigators with multiple research documentation levels (e.g., IRB submissions, educational materials, reports, grant renewal reports, and study forms).
Assist other research personnel with reports to regulatory agencies, such as preparing for and for and assisting with audits, inspections, and monitoring visits from regulatory agencies or sponsors (e.g., IRB, FDA, and Data and Safety Review Committee).
Attend continuing education and training opportunities relevant to job duties.
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.
Serve as a resource or act as a consultant within the area of clinical expertise.
Act as a leader within the department/unit through improving clinical research practice and serving as a resource.
Act as a liaison between hospital staff, university departments, ancillary departments and/or satellite facilities.
Has a solid understanding of human behavior and performance; individual differences in ability, personality, and interests; learning and motivation; psychological research methods; and the assessment and treatment of behavioral and affective disorders.
Applies logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
Performs other related work as needed.
Five years of nursing experience
Current Registered Nurse (RN) license in the State of Illinois or eligibility to receive by start date.
Research certification (e.g., SoCRA, ACRP, Graham School Clinical Trials Management & Regulatory Compliance)
Fundamental working knowledge of clinical research
Knowledge of patient care fundamentals, including aseptic principles and techniques
Ability to provide direct patient care professionally and respectfully
Ability to exercise discretion and confidentiality while handling sensitive situations
Ability to train others
Ability to participate in protocol review and clinical trial evaluations
Excellent interpersonal skills
Excellent verbal and written communication
Strong data management skills and attention to detail
Ability to handle competing demands with diplomacy and enthusiasm
Ability to work collaboratively with faculty and divisional clinical research infrastructure
Excellent time management and ability to prioritize work assignments
Ability to read and understand clinical trial protocols
Working knowledge of Good Clinical Practices (GCP)
Extensive knowledge of Microsoft Word, Excel, and Adobe Acrobat
The Clinical Research Nurse occasionally has study visits that take place in the evenings, overnight, or on the weekends
Cover Letter (required)
Reference Contact Information (required)
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