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TK-CHAIN is a leading solution provider in the life sciences industry, offering a diverse portfolio of services including Clinical Research, Biostatistics, Regulatory Affairs, Computer System Validation (CSV), Gene Therapy, Data Science, and Personalized Medicine.
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Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related interactions.
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Proclinical Staffing is seeking a Senior Director, Regulatory Affairs to join a leading health information technology and clinical research organization. Integrate strategic regulatory & drug development support services into emerging biopharmaceutical company clinical trial offerings.
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Minimum three years of experience in clinical research, regulatory affairs and/or an oncology related field required. Ensures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC and HIPPA. Supports and adheres to US Oncology Compliance Program, to include the Code of Ethics Business Standards.
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Coordinates between all internal/external stakeholders (e.g. Clin Ops, Medical, Pre-clinical, MSLs, Regulatory, Research, Drug supply, Market Access, Commercial, HEOR, Medical Affairs, Publications, Corporate Communications, Investor Relations, Launch Excellence, Alliance Partners as well as Investigators, Patient groups) to ensure alignment, operational efficiency and program success.
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Responsible for working closely with internal and external functions, such as Programming, Biostatistics, Regulatory Affairs, and Project Management. Knowledge of clinical research including regulatory requirement GCP/ICH Data Quality.
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Manages the direction, planning, execution, and interpretation of all the data management activities related to clinical trials/research (Phase I-IV), including participating in defining corporate practices required for handling the data.
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Effectively communicate cross-functionally with Toxicology, Quality Assurance, Regulatory Affairs, Clinical Operations, and Project Management, build consensus and ensure that corporate strategic objectives are accomplished.
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3-5 years’ experience supporting administration of complex research programs as a Study Coordinator, Clinical Research Nurse, Data Manager, Quality Assurance Specialist, Clinical Research Associate (CRA) or Regulatory Affairs Specialist for clinical research studies preferred.
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Supports Director, Oncology Research Program, and Clinical Research Manager in contracting for specific projects, including industry and institution research contracts and confidentiality agreements.
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Develop Standard Operating Procedures (SOPs) and Work Instructions (WIs) as directed by the Senior Director CMC Regulatory Affairs. They are seeking a Regulatory CMC Director or Associate Director who can develop CMC regulatory strategies and prepare CMC submissions for their clinical-stage small molecule drug programs and approved product.
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Lead and shape future clinical development strategy and clinical development plans, working closely with Development and Discovery Program Leads and counterparts in Regulatory, Clinical Development, Clinical Operations, Biostatistics, Clinical Pharmacology, Medical Affairs, Commercial, Non-clinical and Discovery Research for assigned studies.
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Demonstrated experience working at a school of medicine, experience working in student affairs, financial aid, student services or clinical education. Assists with special projects as assigned, including, but not limited to, support for Office of Student Affairs events such as the Student Welcome Event, White Coat Ceremony, and Commencement.
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In collaboration with the AVP for Student Affairs and Wellness, continually review and adapt the counseling service model to ensure student access to a broad range of interventions and modalities (e.g., stepped care, group therapy, peer support) while optimizing the utilization of clinical resources.
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Deliver culturally competent and high-quality clinical care to Caltech students, including individual and group psychotherapy; crisis intervention, including after-hours responsibilities; suicide and homicide risk assessment; and referrals to psychiatry and community providers.
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