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CCRP - Cert Clin Research Prof (Preferred) or RAC - Regulatory Affairs Cert (Preferred) 2 Years experience in a regulatory role or 4 Years experience in related clinical research role (Required.
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As one of the first cancer hospitals in the country, Fox Chase Cancer Center has been a national leader in cancer treatment, research, and prevention for more than 100 years. Temple Health consists of Temple University Hospital (TUH), Fox Chase Cancer Center, TUH-Jeanes Campus, TUH-Episcopal Campus, TUH-Northeastern Campus, Temple Physicians, Inc., and Temple Transport Team. Temple Health is proudly affiliated with the Lewis Katz School of Medicine at Temple University.
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Knowledge of regulatory and compliance requirements for clinical research, including but not limited to, US CFR, ICH, GCP, GDP, EU/UK GDPR. Exceptional knowledge of EC/IRB regulations, regulatory document requirements, expectations, and monitoring of the Trial Master File (TMF.
$138,500 - $153,100 a yearFull-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Master's Degree required (and areas of study should include health policy, research administration, business administration or legal/regulatory). This position provides leadership and guidance in all aspects of the research compliance program, including responsibility for investigation and resolution of research compliance issues; conducting a research compliance risk assessment; maintenance of research compliance policies and procedures; providing regulatory guidance and advice on research compliance matters; and conducting or coordinating focused training and education on research compliance.
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Strong technical writing, strong GMP documentation, strong understanding of assay validation under GMP compliance with regulatory requirements, late stage/commercial stage assay development and validation, life cycle management.
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Five years of relevant experience, Three years as a research administrator preferably with principal investigators/academics Knowledge of relevant regulatory requirements related to IRB and IACUC compliance and demonstrated ability to apply this knowledge.
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JOB SUMMARYUnder the direction of the Director of Licensing and Regulatory Services, provides legal support to in-house counsel, home health, hospice, home care, and senior living operations as part of a dynamic in-house legal department.
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Ensure compliance with regulatory requirements for working with animals in biomedical research, including the Animal Welfare Act & Regulations, the Guide for the Care and Use of Laboratory Animals, local policies, and other applicable regulations.
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Manage customer onboarding and KYC for Capital One Financial Broker Dealers Manage manual screening processes (Bridger Web) Escalation point for Broker Dealer, Investment Bank, Sales, Research and Trading and Mergers & Acquisitions onboarding questions.
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The Certified Group of companies includes Food Safety Net Services (FSNS), Certified Laboratories, EAS Consulting Group, and Labstat International Inc. The Certified Group provides analytical testing and regulatory guidance services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, personal care, tobacco, cannabis, nicotine, and hemp industries.
ExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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The Program Manager will work closely with major internal (PI, ACC CRU Central - Operations, Regulatory, Education/QA, Budget, Legal, Finance, Billing Compliance, Infusion/CHPS, Investigational Drug Services/Pharmacy) and external (sponsors, facilities, CROs, Subcontractors, Collaborators) stakeholders to develop project plans and support day to day operations of clinical research proposals for their team.
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Regulatory Compliance: Knowledge of regulatory guidelines and requirements for conducting in vivo studies, including Good Laboratory Practices (GLP) and Institutional Animal Care and Use Committee (IACUC) regulations.
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Regulatory Coordinator Oncology Clinical Research Unit [CRU] GENITOURINARY Clinical Research Program [GU] Position Description, Occupational Summary Perform regulatory and safety processes for multiple, complex oncology clinical trials and research studies including Investigational Products [IP] for the Duke Cancer Institute’s [DCI] Genitourinary Clinical Research Program [TNA.
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Reporting to the Clinical Research Manager of Blood & Marrow Transplantation and Cell Therapy (BMT-CT), the Clinical Research Coordinator Associate will be conversant in the goals, mission and priorities of the Institute, and utilize this knowledge to to manage data, enroll and follow patients on trial, and assist with regulatory and financial requirements of the trials.
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The Clinical Research Quality & Regulatory Specialist plays an integral role in the data integrity and regulatory compliance of pharmacy services related clinical research.
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