Responsible for the daily operational management of Regulatory Affairs staff; supervisor for 3 direct reports who manage new study start-up across all cancer Disease Working Groups; prioritize new studies in alignment with institutional goals & timelines; assign and track the progress of essential projects; perform quality checks of study binders in preparation for audit and inspection; act as Regulatory representative in audits conducted by sponsors and CROs; liaison between institutional committees, investigators, and industry sponsors; continue to function as Regulatory Lead for Leukemia & Lymphoma Disease Working Groups; utilize knowledge of state and federal regulations & institutional policies to resolve escalated regulatory queries; responsible for staff selection, training, performance management, and discipline; develop training tools and checklists to improve process efficiency; recommend and help develop short and long-term department goals; collaborate directly with department Directors to develop & improve processes in accordance with company strategic plan

Lead regulatory coordinator primarily responsible for leukemia, lymphoma, and myeloma studies; tasked with executing study start-up activities within scheduled timelines; conduct site initiation, close-out, and routine monitoring visits with industry CRAs; write industry study consent forms using site template; report protocol deviations and adverse events to local IRB per guidelines; maintenance of study files; ensure study staff receive protocol training; review informed consent process to ensure compliance with regulatory requirements; mentor to junior regulatory coordinators; represent Regulatory Department in Disease Working Group meetings attended by site physicians; perform quality review of enrolling studies and enact corrective action when necessary; train new employees with or without prior research experience; vocal advocate for process improvement across multiple offices

Regulatory Specialist providing project management for multiple disease groups, with extensive experience in both investigational drug and device study regulation.Ensure that protocols, amendments, adverse event reports, investigator brochures, continuing reviews, and other miscellaneous documents are approved by the IRB, hospital departments and committees, and appropriate federal and regulatory oversight groupsReview the research protocol and prepare study-specific consent formsMaintain records and files in accordance with regulatory requirements, ensuring that all data is entered into the departmental database in a timely and accurate fashionPrepare and maintain regulatory documents such as financial disclosures, FDA form 1572, etc.Serve as the primary liaison for principal investigators, sponsors, IRB, and contract research organizations (CROs)Administer internal documentation of a clinical trial

Quality control functions, including: environmental monitoring of viable and nonviable particles in a clean room, sterile gowning certified, endotoxin assays, hemoglobin tests, osmolality tests, water conductivity tests, species identification tests, radial immunodiffusion assays, micro-organism trending, sterility media preparation, sterility apparatus validation, 9 CFR sterility assays, media growth promotion testingQuality assurance functions, including: standard operating procedure review and revision, official document review, label approval, production line clearance, data compilation for submission to government agencies, new procedure drafting and revision, lab inventory monitoring, deviation and CAPA drafting, root cause analysis, monitoring

Plan and coordinate AAEP trade show appearances, promote Sera products to veterinarians and industry professionals, host webinar training sessions, respond to customer inquiries, develop and revise advertising materials, participated in selection of a new company logo