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Reporting to the VP, Clinical Research Management Dana-Farber Cancer Institute/Dana-Farber/Harvard Cancer Center, the Director will also work closely with the DF/HCC Medical Director for Clinical Trials.
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The CRA/CRC I will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. Our office promotes and facilitates clinical research by providing comprehensive services to physicians conducting clinical trials while ensuring compliance with all regulatory requirements.
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Exceptional matrix team leader, ability to interface with leaders across the enterprise and project teams to develop long range plans and budgets for clinical biomarker pathology technologies aligned with company objectives, identify, pilot and establish new pathology related technologies to meet drug development needs in Ph 1, Proof of Mechanism/Concept, and in registrational clinical trials.
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Prior experience implementing precision medicine approaches in clinical trials including companion diagnostic (CDx) development experience in liquid-based and tumor tissue-based approaches.
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PRINCIPAL DUTIES AND RESPONSIBILITIES: Study Start-Up·Oversight of the clinical trials start-up process from receipt of proposal materials, protocol development, IRB submissions, through site(s) activation.
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Elevate your career with opportunities to conduct research and clinical trials at the esteemed Harvard-affiliated Dana Farber Cancer Center, nationally ranked No. 5 in cancer. While working at Anna Jaques Hospital, you'll also have the opportunity to engage in groundbreaking research and clinical trials at the renowned Harvard-affiliated Dana Farber Cancer Center.
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Deep knowledge of immuno-oncology biology, biomarker strategies and application to clinical trials. Experience in conducting clinical trials and working as part of a clinical study team and other matrix teams.
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Experience in rare disease, pediatric, diabetes or kidney and/or complex clinical trials highly preferred. This position requires a solid understanding of clinical drug development, GCP and regulatory requirements for clinical trials process.
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Oversee and ensure quality control of the pathology team’s methods and data from internal and external labs to support primary, secondary and exploratory endpoints in clinical trials under regulated approaches (GLP, GCP.
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Reporting to the Head of Clinical Supply Chain, the Associate Director of Clinical Supply Planning will focus on managing and optimizing global supplies to ensure timely availability of clinical supplies for clinical trials.
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Provides ad-hoc programming support to Clinical Operations, Data Management, Statistical Programming, Biostatistics, Drug Safety, Clinical Science, Medical Writing and Drug Safety to ensure rapid access to clinical study data for data cleaning/validation, SAS listings review, TLF, dry runs, etc.
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Experience with conduct of clinical research with pharmaceutical/device clinical trials and/or observational or social behavioral and/or public health research. 5 - 8 years relevant experience working as a clinical research coordinator role (project manager, research assistant, study coordinator, etc.
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The Clinical Appeals and Grievance Coordinator (RN) is an integral part of our Appeals and Grievance review process. Provides recommendations on all clinical/pharmacy appeal cases for medical director review.
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Lead internal and outsourced development and qualification or validation of biomarker assays for clinical trials, applying experience across relevant methods (e.g. qPCR, digital drop PCR, Western blotting), to develop robust assays, generate and analyze data and provide expert interpretation of the effects of promising drug candidates.
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You will significantly contribute to development of clinical trials including the focus on biomarker plans development and data review and interpretation. Collaborate with Research teams to bridge non-clinical data into clinical development, and establish credible, clinically based biomarker, and cellular kinetics plans, as well as clinical data review.
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review clinical trials jobs Title: manager clinical Company: Cpc Clinical Research in Brookline, MA
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