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We want you to apply Job Summary and Qualifications The IRB Coordinator coordinates complex and broad administrative matters for the Institutional Review Board (IRB). Submit your application for our Institutional Review Board (IRB) Coordinator opening with Medical City Plano today and find out what it truly means to be a part of the HCA Healthcare team.
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Activities may include providing assistance with establishing and maintaining trial regulatory files, coordinating FDA and IRB filings, establishing and maintaining electronic data systems to facilitate data capture and storage across multiple trial sites, site startup and closeout activities, maintaining trial participant records, and assisting with periodic internal site audits for multiple clinical trials.
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The IRB Coordinator coordinates complex and broad administrative matters for the Institutional Review Board (IRB). If you find this opportunity compelling, we encourage you to apply for our IRB Coordinator opening.
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Understand and be able to assist others in understanding the basic Federal and Duke University rules, regulations and requirements of IRB, IACUC, COI, IBC and Misconduct Science. - Provide guidance to the PI on the requirements of the IRB, IACUC, COI, IBC, and research related regulations including proposal submission and award set-up.
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Lead the regulatory evaluation of IRB research protocols by the Human Subjects Protection Program. At least five (5) years of related experience including IRB, medical research, or legal/regulatory experience.
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Stakeholder Collaboration: Work closely with investigators, IRB staff, and research personnel to address Medicare Coverage Analysis issues and ensure compliance. Medicare Compliance: Assess research protocols to determine the necessity for formal Medicare Coverage Analysis (MCA), in accordance with CMS policies.
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Submits documentation to the Institutional Review Board (IRB) autonomously and follows the process to ensure approval. Coordinates non-therapeutic (i.e. minimal risk, survey, chart review) clinical research protocols with direction from the principal investigator and/or supervisor in compliance with regulatory laws and institutional guidelines.
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Reports to the Institutional Review Board (IRB), completing IRB review reports and assisting with drug accountability. The Clinical Research Coordinator 2 assists various Principal Investigators (PI), through delegated authority, in conducting clinical trials during all phases of trials including pre-study implementation through study closure per federal, state and Institutional guidelines.
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The Health System encompasses Duke University Hospital, Duke Regional Hospital, DukeRaleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, theDuke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health.
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Leads or collaborates on required tasks prior to commencement of clinical trials that include, but are not limited to: clinical planning, protocol development, case report form (CRF) development, IRB submissions, investigator agreements, informed consent form (ICF) development, site selection and communication with clinical trial sites regarding all logistics including contract agreements, support materials and training.
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We are seeking an IRB Coordinator for our team to ensure that we continue to provide all patients with high quality, efficient care. Referral services for child, elder and pet care, home and auto repair, event planning and more.
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Attend regularly scheduled research meetings to report on progress of various projects; review relevant literature; brainstorm project ideas; perform data collection; complete IRB paperwork; write abstracts, articles and book chapters; create posters and presentations for research meetings/conferences; and attend conferences/research meetings, and grant writing.
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Previous experience as a clinical research coordinator, clinical research associate, or related role is preferred. Rich with visual and performing arts venues, museum districts, professional and semi-professional athletics teams, botanical gardens, accessible trails and so much more, the Dallas-Fort Worth (DFW) metroplex has something for everyone to explore.
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