Qualifications
Responsibilities
Benefits
Department
BSD PED - Clinical Trials Office
Job Summary
Responsibilities
Ensure compliance with each study’s protocol by providing thorough review and documentation at each subject study visit.
Participate in recruitment and selection of study participants by interviewing and documenting medical history to determine compliance with eligibility requirements.
Perform medical tests, collect labs, and administer investigational medications and perform patient assessments during clinic visits to determine presence of side effects; notify Principal Investigator of findings/issues.
Provide patient education and medical information to study patients to ensure understanding of proper medication dosage, administration, and disease treatment.
Document medical data in patient chart to capture protocol requirements. Provide accurate and timely data collection, documentation, entry, and appropriate reporting to sponsors and institutions.
Support regulatory components and site research compliance for study feasibility, study start-up, ongoing study monitoring, and site close out.
Provide training and mentorship to clinical research team on clinical trial assessments, best practices for clinical research visits, and ALOCA+ data maintenance.
Serve as liaison between PI, sponsoring agent, regulatory groups, patient, family members, referring MD's/community MD's, pharmacist, statistician, and other members of the research team.
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.
Minimum Qualifications
Education:
Minimum requirements include a college or university degree in related field.
Work Experience:
Certifications:
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Preferred Qualifications
Education:
Bachelor of Science Degree in Nursing.
Experience:
Experience with obtaining consent and assent, and supporting clinical teams in regulatory preparation (IRB applications, amendments, informed consent).
Experience with industry sponsored clinical trials and the regulatory components of those studies.
Two years of clinical nursing experience with demonstrated clinical competence in patient care, teaching and management of patient treatment plans, and knowledge about clinical research including protocol therapy and data management.
Licenses and Certifications:
Current licensure as a registered nurse in the State of Illinois from the National Council Licensure Examination for Registered Nurses (NCLEX).
Registered Nurse with a current Illinois license.
Preferred Competencies
Fundamental working knowledge of clinical research.
Ability to train internal staff, coordinate compliance, and participate in audits/inspections to address regulatory findings.
Knowledge and ability to provide direct patient care, including aseptic techniques, in a professional and respectful manner.
Excellent verbal and written communication, and ability to read relevant documents and instruments.
Ability to perform multiple concurrent tasks with occasional interruptions and adapt to changing working situations and work assignments.
Ability to exercise discretion and confidentiality while handling sensitive situations.
Ability to solve problems by applying math or reasoning principles.
Application Documents
Resume (required)
Cover letter (required)
When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.
Job Family
Role Impact
Scheduled Weekly Hours
Drug Test Required
Health Screen Required
Motor Vehicle Record Inquiry Required
Pay Rate Type
FLSA Status
Pay Range
The included pay rate or range represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting.
Benefits Eligible
The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.
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