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the consent process is performed in compliance with institutional, FDA, IRB, clinical trial sponsor and other applicable regulations.
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/transfer process for all patient types. Performs accurate collection of patient demographic and insurance information, to be verified upon each patient registration. Performs check-in, check-out process
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with the QA Officer for preparedness for inspections by regulatory agencies so that there is a positive outcome and a minimum disruption in the daily operation and ensure that agency inspectors
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of new and improved techniques. Ensure that all laboratory activities are carried out in compliance with each procedure(s) by utilizing safety procedures and guidelines in handling, storage and disposal
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candidate you will: · Shepherd protocols through the C/PRMC and IRB review processes to achieve a timely outcome that is compliant with applicable regulations. · Manage new protocols
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protocol deviations. Manage patient/family phone calls – collaborating with MD, NP and/or PA as needed to obtain orders for the management of the patient. Ensure the consent process is performed in
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research-related documents. You will serve as a project manager, navigating the regulatory review process for each research study, ushering manuscripts through the submission and revision process, and
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tissue collection), DNA extraction, PCR analysis, histological techniques, fluorescent microscopy, computer skills (word processing, email, spreadsheet management, adobe photoshop, Image J), and lab
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, RT-PCR, and cytotoxicity assays, under minimal supervision. You will provide supervision and training to junior team members and support the qualification and validation of manufacturing processes and
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. Ensure the consent process is performed in compliance with institutional, FDA, IRB, clinical trial sponsor and other applicable regulations.