eTeam

Job Title: CLINICAL RESEARCH NURSE. Required: CA RN license, CCRC or CCRP certification and 1+ years of exp in the Clinical Research field. Under the supervision of the Clinical Research Program Manager, the Clinical Research RN ensures the integrity and quality of clinical trials are conducted and maintained in accordance with federal, state, and local regulations, Institutional Review Board (“IRB”) approvals, and Healthcare System policies and procedures.. Actively participates in study specific site feasibility and trial activation, overall quality assurance, and research regulatory and billing compliance of active clinical trials at the Salinas Valley Medical Clinics.. Ensures adherence to applicable rules and guidelines of governing bodies such as FDA, HHS OHRP, TJC, HIPAA, CFR and GCP.

clinical research

Job Title: CLINICAL RESEARCH NURSE Location: Salinas, CA  Pay: $70 - $80/hour Duration: 13 weeks Shift: Days, 5x8 hours Required: CA RN license, CCRC or CCRP certification and 1+ years of exp in the Clinical Research field Duties:<ul><li>Under the supervision of the Clinical Research Program Manager, the Clinical Research RN ensures the integrity and quality of clinical trials are conducted and maintained in accordance with federal, state, and local regulations, Institutional Review Board (“IRB”) approvals, and Healthcare System policies and procedures.</li><li>This position is primarily responsible for the accurate completion of visit procedures and collection of information from study patients according to protocols, and for protecting the health, safety, and welfare of research participants.</li><li>Supports and serves SVMHS research customers, inclusive of patients who have consented or are considering consent to participate in IRB-approved clinical research protocols, and the principal investigators who wish to conduct research involving human subjects.</li><li>Follows the Principles of Good Clinical Practice (GCP) in the oversight of clinical research activities at SVMHS.</li></ul>Skills:<ul><li>Demonstrates the ability to coordinate Research and Data activities in a hospital or other setting independently.</li><li>Collaborates with Physicians, clinical staff, ROC, external-IRB and clinical trial sponsors.</li><li>Is a role model for departmental behavior, and provides and promotes a positive working environment for departmental staff to ensure strong employee morale, motivation and productivity.</li><li>Actively participates in study specific site feasibility and trial activation, overall quality assurance, and research regulatory and billing compliance of active clinical trials at the Salinas Valley Medical Clinics.</li><li>Serves as the liaison between research affiliates, hospital partners and external vendors/partners (e.g. commercial IRBs and pharmaceutical and medical device manufacturers).</li><li>Provides information on state of clinical trials at SVMHS and opportunities for collaboration or participation by component institutions.</li><li>Facilitates & monitors compliance with study procedures and GCP standards including but not limited to proper screening of study subjects, Informed Consent forms are explained to study participants and all required signatures are obtained prior to treatment, and subject safety throughout the participation in the trial.</li><li>Facilitates site feasibility review (e.g., space, equipment, laboratory services, and pharmacy services) prior to study initiation.</li><li>Ensures adherence to applicable rules and guidelines of governing bodies such as FDA, HHS OHRP, TJC, HIPAA, CFR and GCP.</li></ul>

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