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Acts as a representative of clinical research and as liaison between investigators, other study staff, primary care providers, IRB and sponsor. Assists as needed in preparing study for submission to IRB and ensures all regulatory documents are completed.
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Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), Certified IRB Professional (CIP) or Certified IRB Manager (CIM) Conducts the preliminary preparation of IRB submissions to ensure completeness, compliance with administrative requirements, accuracy and scientific validity consistent with regulatory requirements and local policies.
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Demonstrated knowledge and understanding of human research policies, regulations, procedures and standards as according to HIPAA, IRB, FDA, ICH, and GCP guidelines is required. Ensures study documents are maintained in compliance with applicable regulations, guidelines, and policies (i.e. FDA, OHRP, IRB.
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Data Management and Compliance: Lead data management planning and ensure adherence to regulatory standards like IRB, HIPAA, GLP, GCP, and FERPA. Evaluation and Reporting: Collaborate with the Senior Director to evaluate the Research Technology Core's effectiveness through detailed reports and data analysis.
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Essential Duties and Responsibilities include: Acts as liaison between investigators, other study staff, primary care providers, IRB and sponsor. Our multi-disciplinary team approach includes surgical oncology, medical oncology, radiation oncology, women's centers, diagnostic imaging services, integrative services including social work and nutrition, and genetic counseling.
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Serves as a representative at the Institutional Review Board (IRB). The comprehensive network encompasses six acute-care hospitals, an extensive medical group with primary, specialty and urgent care services, a cancer care network, outpatient surgery centers, clinical research, medical education, a foundation, an accountable care organization, community services and more.
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Prepares maintenance program revision submittal approvals for presentation to the IRB. Presents selected or requested modifications to the IRB for approval. Hold a Mechanic's certificate with Airframe and Powerplant ratings(preferred.
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The PI is responsible for the safety of subjects who participate in clinical trials and for executing the study according to the IRB-approved protocol and applicable FDA and GCP regulations. Review all serious adverse events and SUSARs to the Sponsor and IRB within statutory timelines.
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Serve as liaison between Creighton University School of Medicine - Phoenix and IRB leadership within Alliance members. This role will serve as the primary point of contact for Creighton medical students, residents, and fellows in Phoenix for instruction around how to initiate research projects, provide connection to mentors and resources, and assist in navigating the Alliance member IRB processes.
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The selected candidate manages and coordinates all facets of assigned clinical protocols from IRB preparation through query and data seal; ensuring protocol and regulatory compliance. Our Cardiovascular Research Program and Women's/Infants Research Program is seeking a Clinical Research Nurse to join our team.
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Adhere to an IRB approved protocol. Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with clinical trial master filing systems.
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Serve on dissertation committees or in an assigned role as a project chair, resource specialist, research methodologist, statistician, IRB expert, or panel validator; develop and maintain strong relationships by serving as a program resource for college and/or academic staff, faculty and students, and serve as a liaison for the College.
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Opening: Clinical Research Coordinator. Acts as a liaison between Sponsor, Investigator, and Study Subject. Collaborates with Investigator to identify adverse events/ serious adverse events to ensure study subject safety and accurate and timely reporting.
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Helps with the implementation of quality assurance plans and conducts audits of clinical research activities to ensure compliance with funding source requirements, IRB standards, and federal/state regulations.
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Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time.
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irb job in Tempe, AZ
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