Oncology Clinical Research Nurse Position

4 weeks ago


Augusta, Maine, United States InsideHigherEd Full time
Oncology Clinical Research Nurse Job Summary

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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