Under the direction and supervision of the Clinical Research Manager, the Clinical Research Nurse facilitates the start-up, implementation, accrual and ongoing maintenance of clinical research studies. The position arranges and oversees all clinical trial activities and plays a key role in assisting the Principal Investigator (PI) and Co-Investigators in recruiting patients for clinical studies.
Participates in a variety of clinical research projects/studies involving various modalities of treatment for patients, including multi-centered cooperative group and intergroup trials at a national level, multi-institutional pharmaceutical trials, and single and multi-centered trials, designed, implemented, and coordinated in the Section of Cardiology.
Participates in established and future research programs. Provides assistance to the Regulatory Coordinator with IRB submission. Advises the investigator and research staff about the submission process and provides instructional material for reference. Works with PI, CRO's, sponsoring agencies, Department of Medicine Administration staff, and Office of Research Services to advise on initial and amendment submissions, changes or corrections to protocols/and or consent forms, and ongoing training.
Advises administrators about clinical trial agreements. Sets up shadow files, databases, screening logs, adverse event reporting mechanism.
Trains and participates in trial related activity from the initial entry to complete follow-up of patients enrolled into research protocols.
Reports adverse drug reactions and submits the appropriate documentation to the FDA, NCI and IRB.
Coordinates all tests specified by the study and additional tests at the discretion of the PI to evaluate toxicities and treatment.
Coordinates research billing with the billing department.
Educates potential research subjects concerning clinical aspects of their disease, purpose and nature of the protocol, and impact on the patient should they agree to participate (i.e. treatment schema, tests, clinic visits, etc). Consents patients to clinical research study, and completes relevant documentation. Teaches patients and their family members how to administer injections and signs and symptoms of side effects (where appropriate). Provides family education depending on patient's illness and route of medication delivery. Develops resources and materials for patient and family teaching if none exist. Provides in-servicing and educating both the nursing units and lab staff regarding upcoming and ongoing protocols.
Collects, processes, tracks and ships biological samples, as indicated by protocols.
Enters study data into local and/or sponsoring agencies databases, schedules and facilitates monitoring visits, and resolves queries issued by sponsoring agencies.
Current licensure as a registered nurse in the State of Illinois from the National Council Licensure Examination for Registered Nurses (NCLEX) required. A minimum of a bachelor's degree in Nursing required.
Relevant Job Experience
Two years of experience in nursing with demonstrated knowledge about home care, palliative care, advance directives, pain management, symptoms control, and/or discharge planning required. One year industry sponsored research experience required.
Additional Salary Information: Based on experience.
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