Play a key role in new and ongoing clinical trials.
Responsible for compliance with applicable UChicago and Federal Policies and procedures for research. Review protocols and informed consent forms for new and ongoing studies, identify, and communicate potential issues to the appropriate personnel.
Participate in the execution of study-related activities of observation and clinical research studies conducted in the medical center and in the community.
Maintain safety andconfidentiality of study subjects throughout the study. Maintain accurate and complete source data.
Evaluate adverse events and manage safety reporting activities in a timely manner.
Participate in nursing study related activities as required by protocol in compliance with UChicago and study sponsor SOPs and external (Code of Federal Regulations (CFR), International Conference on Harmonization (ICH), and Good Clinical Practice (GCP) regulatory guidelines.
Communicate with the Principal Investigator and other Institute for Population and Precision Health (IPPH) leadership to organize study-specific nursing activities.
Participate in quality and compliance improvement initiatives and provide feedback as appropriate.
Facilitate training of new and existing personnel and ensure management is apprised of trainee progress.
Provides study support as assigned within a defined scope, actively supports area projects/goals and completes delegated activities as assigned. Workload responsibilities are study-related and have a major impact on regulatory compliance.
Interprets assessments, treatments, outcomes, work and disability status, and screenings in a thorough manner. Maintains clear and concise records for individual and corporate clients to meet the requirements of the department, the company and any applicable standards or laws.
Analyzes test data or images to inform diagnosis or treatment.
Has a solid understanding about drug regimens and possible side effects or interactions with other substances such as food supplements, over-the-counter (OTC) medications, or herbal remedies.
Participates in counseling patients about prescribed therapeutic regimens, normal growth and development, family planning, emotional problems of daily living, and health maintenance. Interprets patient's condition quickly and concisely and determine the best course of treatment. This can include ordering appropriate laboratory or imaging studies, discussing patient with the Emergency Physician and/or referring patient to consultants.
Performs other related work as needed.
An advanced degree (or equivalent, if license received prior to July 1, 2001) from an accredited school/college of nursing
Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.
Ability to obtain Illinois advanced practice nurse (APN) license by start date.
The candidate must be able to present study related issues, orally and in writing, in a clear and concise manner. Problem solving involves identification of problems and proper escalation to Management. Follows scientific arguments and identifies study data and source document issues and seeks solutions with minimum guidance. Complies with proper documentation practices and utilizes sound GCP standards and regulatory guidance. Impacts subject safety, study data integrity, and product/study approval.
Good understanding of ICH/FDA regulations and guidelines affecting clinical research issues. Understanding of the IPPH SOPs. Clinical knowledge to apply to adverse event assessment and data collection. Computer proficient (e.g. Windows, Word, Excel).
Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance. Creates a learning environment, open to suggestions and experimentation for improvement. Embraces the ideas of others, nurtures innovation and manages innovation to reality.
Learns fast, grasps the "essence" and can change course quickly where indicated.
Cover letter (preferred)
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Staff Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via the Applicant Inquiry Form.
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Internal Number: JR09279
About University of Chicago (UC)
One of the world's premier academic and research institutions, the University of Chicago has driven new ways of thinking since our 1890 founding. Today, UChicago is an intellectual destination that draws inspired scholars to our Hyde Park and international campuses, keeping UChicago at the nexus of ideas that challenge and change the world.