Oncology Research Specialist - Regulatory Affairs & Compliance - FT

Department: 80096 Carolinas Medical Center - LC: Clinical Trials: Morehead Status: Full time Benefits Eligible: Yes Hou rs Per Week: 40 Schedule Details/Additional Information: Primarily works in remote/home-based setting in the Charlotte regional area. Candidate must reside in the Greater Charlotte area due to possible on-site requirements. M-F, 8am-5pm Additional Essential Functions Assists with regulatory and other compliance documentation associated with oncology research projects/clinical trials. Compiles, prepares, reviews, and submits protocol submissions from study start-up through study termination, including amendments, safety reports, renewals, etc. Participates in the research study start-up activity, working with the PI and others to initiate new research projects within activation timelines. Maintains and assures all assigned study regulatory obligations are managed compliantly in accordance to standard procedures. Maintains documentation for assigned studies in an audit-ready manner and assists in the preparation of site audits and FDA inspections. Serves as study liaison to the IRB. Assists in timely filing of documents and maintains electronic data repositories and other electronic systems. Assists with the development of and maintains process guidelines to ensure procedural compliance Assists in the monitoring of clinical trial compliance by reporting issues and problems appropriately. Communicates with research team, sponsors, and IRB on the status of assigned studies. Additional Training and Certifications Must speak/write clearly in English. Pay Range $25.30 - $37.95 Essential Functions Assists with clinical, regulatory, business, and other documentation associated with oncology research projects/clinical trials within department. Participates in the study project start-up activity, works with the PI and others to initiate new research projects. Maintains protocol amendments, deviations, and informed consent changes regarding oncology research studies, assures all documentation is managed compliantly and maintained in an audit-ready manner. Maintains appropriate documentation for assigned studies. Assists in maintenance of filing systems, data repositories and systems. Assists in the monitoring of clinical trial compliance by reporting issues and problems appropriately. Obtains required documentation and to assess patient eligibility for research studies. Contacts local research staff to confirm scheduling of tests/treatments required by protocol. Obtains and completes data for patients enrolled on clinical trials. Physical Requirements Primarily works in an office setting. Requires full range of body motion; sitting for extensive periods of time; walking, standing, reading, and writing/keyboarding. Occasionally lifts and carries items weighing up to 35 pounds. Requires corrected vision and hearing within normal range. Must speak and read/write clearly in English. Must be able to be mobile within the entire healthcare system and other locations that participate in clinical trials. Education, Experience and Certifications High School Diploma or GED required; bachelor's degree preferred, Health/Science preferred. Experience in a healthcare setting preferred, especially cancer care and/or clinical research. Certification in clinical research (SoCRA, ACRP, RAPS, etc.) preferred. 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Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation’s largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. 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