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: Under supervision, assists with managing investigational products (IP) including arrival, storage, and handling (requisitions, inventory, and reordering). Under supervision, prepares for study monitoring
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execution and approval processes. • Oversee investigational product (IP) management for multiple studies, including documentation, handling methods, and compliance. • Develop, optimize, and manage systems
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and procedures. May delegate tasks and supervise the activities of other licensed and unlicensed research staff. Is responsible for all aspects of managing and documenting Investigational Product (IP
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. May delegate tasks and supervise the activities of other licensed and unlicensed research staff. Is responsible for all aspects of managing and documenting Investigational Product (IP); including
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. May train others in these policies and processes. Is responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage, tracking, and provision to research
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. Operations: Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. Prepares FDA regulatory submissions in collaboration with ORAQ, including development
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. Collect, prepare, process, ship, and maintain inventory of research specimens. Assist with management of IP. Employ the required system for handling, dispensing and documentation of IP for sponsored
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, protocol submissions, and SOPs. May train others in these policies and processes. Is responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage, tracking
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-to-day regulatory and safety operations for multiple, complex oncology clinical trials and research studies, including those involving Investigational Products (IP). Your work will ensure compliance
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the collection, compilation, documentation, and analysis of clinical research data. May oversee the work of junior staff and train or mentor others in clinical research tasks. Provides and documents professional