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Field
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staff. Maintains equipment and supply records and assists with purchasing and inventory tracking. Coordinates laboratory access, onboarding, and required training to support IRB compliance and processing
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clinicians across LCCC consortium sites. Institutional Departments and Staff: Institutional Review Board (IRB), Office of Research Quality Assurance (ORQA), Clinical Research Operations Office, MedStar Health
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participant compliance with smartphone-based real-time monitoring. Prepares IRB applications, renewals, and amendments. Serves as a liaison for study staff and training and coordinating volunteer students
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physician-scientists, cares for 20,000 patients annually, and is home to more than 160 employees, plus all the physicians and clinical staff engaged in cancer patient care. The link to our website is: https
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. In some cases, Specialists serve as the designated final review of protocols. Duties & Responsibilities Management of IRB Protocols: Performs regulatory review and analysis of research applications
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with the PI, IRB, sponsoring agency, community and the study participants. The role will be responsible for managing and recording all phases of study protocol as required by GCP and sponsoring agencies
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Ability to quickly learn new clinical research systems (e.g., iRIS, OnCore, eREG Forte) Experience with regulatory submissions (IRB, IND, FDA forms) and clinical trial compliance Other Requirements: Ability
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efforts. • May participate in IRB approved research projects. • May perform other duties as assigned. Supervision Received General supervision from assigned supervisor. Supervision Given Direct supervision
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dissemination activities. The VHO will also be responsible for managing IRB approvals, including tracking modifications and renewals, and will lead single IRB processes with collaborating sites. Minimum
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accordance to study sponsor, primary investigator, and regulatory agency specifications. Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB