Clinical Research Institute RN

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JOB SUMMARY / PURPOSE 

The Clinical Research Nurse (CRN) works with the CommonSpirit Health Research Institute Market Clinical Research Manager (MCRM), Principal Investigators, co- and sub-investigators, clinical and ancillary departments, IRBs, and industry or government sponsors of research to plan, coordinate, implement and complete clinical trials and other research projects managed by the CommonSpirit Health Research Institute. The incumbent has responsibility for the oversight of studies that explore complex medical diseases, which involve specialty and subspecialty expertise. The incumbent serves as clinical nursing knowledge role model in the care of research participants, performing clinical procedures and assessments of research participants that are appropriate within the RN scope of practice. In conjunction with the PI and other facility/clinic staff, s/he may provide direct patient care related to a research protocol. 

Essential Key Job Responsibilities 

• Perform clinical assessments of research participants, including blood pressure, heart and respiratory rates, brief physical exams, EKGs, and other clinical testing appropriate within the RN scope of practice, i.e., NIH Stroke Scale, NYHA and CCS class. 
• Perform clinical procedures per research protocols, including blood draws, injections, and other procedures appropriate within the RN scope of
• Dispense study medication to research participants under the direction of the PI, and/or coordinate study drug administration with hospital/clinic Pharmacy staff. 
• Process labs for clinical trials, including collecting, centrifuging and aliquoting specimens, and ship specimens in accordance with federal biologics shipping regulations. 
• Identify and report all unanticipated and other adverse/serious adverse events, as well as protocol deviations, violations or exceptions, to the study sponsor and IRB as required by GCP, FDA, OHRP and CommonSpirit Health policy. 
• In conjunction with the PI and other facility/clinic staff, may provide direct patient care related to the research protocol. 
• Conduct informed consent process with research participants; document informed consent discussion and obtain signatures per protocol, federal, state and institutional requirements. 
• Coordinate all study-required visits, procedures, tests and activities to meet protocol requirements; schedule participant appointments with appropriate provider/facility. 
• Prepare, manage and submit all required any required study/regulatory, documents, applications and forms, including but not limited to the applicable Institutional Review Board (IRB) application form(s), informed consent documents, 1572 forms, Conflict of Interest forms, and other forms as required by the sponsor, IRB, or CommonSpirit Health. 
• Prepare for, coordinate and participate in sponsor monitoring visits or internal/external audits; resolve queries and other findings promptly; prepare responses or corrective actions plans as needed.
• Determine effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials. Actively recruit, screen and enroll participants in trials. 

Required Education and Experience

• Graduate of an accredited school of Nursing required; BSN preferred; OR Current RN license and Bachelor’s degree, preferably in a science or health-related field, required.
• Current California RN license required.
• Minimum of 3 years of nursing experience with patients in a healthcare setting required, preferably in relevant clinical area (e.g., cardiology, oncology, neurology).
• Minimum 3 years of experience conducting clinical trials required; worked as primary research nurse for at least 5 drug or device trials.
• Experience in implementation of research protocols and clinical trials processes required.
• Experience in preparing and maintaining regulatory documents and other IRB-related study documentation required.
• Lab processing experience required.
• BLS certification required.
• Eligibility to sit for the exam within one year of hire or Current certification (CCRP or CCRC) by the Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) required.
• Current certificate of Human Subjects Protection and Good Clinical Practice training required.

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