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| Assistant Director of Clinical GA Open (J#39804) Title: Assistant Director of Clinical Company: Emory University Job Description: Provides support for the clinical research program of the Winship Cancer Institute by managing the process by which trials are reviewed and approved through the internal review process. Supervises and supports regulatory specialists in preparing and submitting required documentation to the Emory IRB, OSP, RSC, COI and OCR for approval of all clinical research trials conducted at Winship. Provides regulatory support for more than 120 current clinical trials and handles annual renewal applications for over 300 protocols. Assists regulatory specialists in writing, with the input of the Principal Investigator and research nurse, informed consent documents for all protocols or, where appropriate, assists in the assurance that the informed consent document prepared by a sponsor or cooperative group meets the requirements of the Emory IRB. Assures that all IRB renewals are properly prepared and submitted in a timely manner. Prioritizes projects to effectively manage the departmental workflow. Develops and implements templates for reports, Clinical Trials Research Committee (CTRC) submissions, etc. Prepares a variety of reports for management and the use of the CTRC and Working Groups, including monthly pipeline and accrual reports. Develops, implements and maintains templates and SOPs for the regulatory affairs office. Assures HIPAA compliance for protocols, consent documents, databases, etc. used in the conduct of clinical research at Winship. Assures all required regulatory files are maintained. Works with internal offices (IRB, OCR, ORC, etc.) to ensure compliance and develop SOPs. Works closely with the Director of Clinical Research and the Director of Education and Outreach to develop and improve process and communicate pertinent information. Serves as the main point of contact for regulatory issues for sponsors, cooperative groups or federal agencies. Directs administrative support for the CTRC. More... | |||
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