CommonSpirit Health was formed by the alignment of Catholic Health Initiatives (CHI) and Dignity Health. With more than 700 care sites across the U.S., from clinics and hospitals to home-based care and virtual care services, CommonSpirit is accessible to nearly one out of every four U.S. residents. Our world needs compassion like never before. Our communities need caring and our families need protection. With our combined resources, CommonSpirit is committed to building healthy communities, advocating for those who are poor and vulnerable, and innovating how and where healing can happen, both inside our hospitals and out in the community.
Coordinates clinical research and study services in support of specified pharmaceutical, cooperative group or medical device research, and for ensuring that all clinical activities are carried out in accordance with the established protocol. An incumbent relies on the expertise of the Principal Investigator(s) and other clinical staff for insight and direction relative to matters involving clinical determinations and for guidance in assuring that studies are conducted within acceptable clinical procedural and safety standards.
Work includes planning and executing procedures for screening, enrolling, monitoring and retaining clinical research subjects in accordance with established study protocol(s), FDA (Federal Drug Administration) regulations, Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines for clinical trials and research study management. An RN incumbent must be fully conversant with nursing practices sufficient to elicit timely and accurate information with respect to side effects experienced by study/protocol participants, and to take appropriate action within the defined scope of responsibility.
Work is performed under rigorous conditions relating to the accuracy of study data, and is subject to frequent audits to validate that the information on CRF (Case Report Form) and other source documents are consistent and correct
Two years of experience as a Clinical Research Coordinator (or equivalent)
Experience in an oncology care environment preferred
Related skills:clinical, research protocols, edc, mrec, investigators, crf, fda
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