Oncology Clinical Research Nurse Position
4 weeks ago
This position provides research coordination for assigned oncology studies. The duties include, but are not limited to:
Clinical Trials:
Review study protocols, primary disease category, and investigational drug information; be familiar with all study requirements; communicate and make arrangements with different areas of AU that may be involved in the study; set up studies according to sponsor requirements and IRB policies.
Reports and Financial Documentation:
Complete all reports, including the annual study continuation report required by IRB; prepare forms and submit investigational New Drug (IND) Safety Reports to the IRB.
Medical Management:
Assess patient's general health; accurately report all adverse events within required time frame to sponsor and IRB; notify Principal Investigator of patient's condition; provide assistance to Principal Investigators for management of adverse events; schedule any required follow-up procedures for resolution of adverse events.
Conduct of Study:
Schedule patient visits, laboratory tests, and procedures; under the direction of the Principal Investigator, dispense investigational drugs per protocol and AU requirements; obtain laboratory samples; obtain vital signs, perform ECGs when required, and assist physician with physical examinations; conduct Good Clinical Practices.
Recruitment of Subjects:
Be familiar with inclusion/exclusion criteria; prepare recruitment plan with Principal Investigators; prepare any advertisements for institutional approval; prepare correspondence to potential sources for patient accrual; become the liaison between sources of referral and Principal Investigator; screen patients for inclusion/exclusion criteria; verify informed consent procedures.
Study Documentation and CRF Completion:
Help maintain all FDA and sponsor required regulatory documents; ensure documentation and reporting of required procedures/tests and study information; accurately complete source documents; work with data coordinators to accurately complete case report forms and other data entry in a timely manner; enter patient information into OnCore.
Requirements:
Bachelor's degree in Nursing from an accredited college or university and licensed to practice as a Registered Nurse in the state of Georgia with a minimum of three years of clinical experience in a specialized area; current American Heart Association Healthcare Provider BLS/BCLS certification OR Associate's degree in Nursing from an accredited college or university and licensed to practice as a Registered Nurse in the state of Georgia with a minimum of six years of clinical experience in a specialized area; current American Heart Association Healthcare Provider BLS/BCLS certification.
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