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Regulatory Coordinator Oncology Clinical Research Unit [CRU] Brain TUMOR CLINICAL Research Program [BTC] 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] TEAM Clinical Research Program [BTC.
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The Infectious Disease Clinical Research Consortium (IDCRC) is an NIH award to support the planning and implementation of clinical research that addresses the scientific priorities of NIAID in evaluating vaccines, other preventive biologics, therapeutics, diagnostics, including prognostics and predictive markers, and devices or the treatment and prevention of infectious diseases.
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BA/BS degree in life sciences, clinical research information technology, computer science, or related field preferred. Strong knowledge of medical terminology, FDA regulations, ICH guidelines, and Good Clinical Practices and their application to clinical trials.
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Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.
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This role will interact closely with members of Clinical Operations, Research Oncology, Abstraction, Abstraction Operations, Product Operations, Life Science Partners, and other key stakeholders within Clinical Research & Real World Evidence(RWE.
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18+ months Clinical Research Associate (CRA) monitoring experience in clinical research with understanding of clinical trials methodology and terminology. As a Clinical Research Associate at Parexel, you will be joining a team with a wide variety of experiences and knowledge.
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The Associate Director, Statistical Programming will lead the clinical Statistical Programming function with full accountability for SP activities including SDTM, ADaM and statistical outputs; will collaborate with partner functions in Clinical Development Department (e.g., Clinical Operation, Clinical Research, Biometrics) and oversee the vendor SP counterparts.
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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] TEAM Clinical Research Program [BTC.
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Desirable experience includes prior role as a lead statistician on clinical trials and/or clinical research projects that have delivered the agreed-upon end products on time, and prior guidance of lower level or less experienced staff.
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This role offers a flexible work-from-home arrangement, enabling you to engage in various activities such as online surveys, focus groups, clinical trials, product tests, and optional delivery services for food and groceries.
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Join Duke Health colleagues at tumor boards, clinical trials research, and have the opportunity to teach Duke Hematology-Oncology fellows in the clinic. This physician partners with community-based and rotating Duke Health Oncologists, an on-site Duke breast surgeon, APPs, Duke Radiation Oncology, on-site specialty pharmacy and has robust clinical services support.
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Solid understanding of clinical research methods, Clinical Data Interchange Standards Consortium (CDISC) principles, best data management practices and technologies related to clinical trials.
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Actively participate in online surveys, focus groups, and clinical trials as needed. By participating in these opportunities, you can shape product development while earning extra income.
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Embrace opportunities for personal and professional growth. If you are interested in joining our team, please submit your application through our online portal. Communicate effectively with project coordinators and adhere to guidelines.
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Adhere to project timelines and follow instructions provided by our platform. We eagerly anticipate reviewing your application and potentially welcoming you to our team! Include your contact information and a brief statement explaining why you are well-suited for this role.
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clinical research trials jobs in Durham, Leesburg, District Of Columbia
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