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The role represents the CPQP function on drug development teams, leads CPQP sub-teams, and owns strategy and delivery on posology for early and late-stage clinical trials while collaborating with clinicians, clinical operations, bioanalytical, biomarker, pharmacovigilance, regulatory and CMC groups.
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We are looking for a self-directed professional to support Digital Health Technology [DHT] (wearable sensors) and imaging components set-up and monitoring within clinical trials; specifically focused on the operational initiation/set-up, vendor and digital data/imaging monitoring, and data cleaning process efforts that occur within the Biomeasures Endpoints and Study Technologies (BEST) projects.
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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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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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The laboratory of Dr. Pradeep Natarajan at the Massachusetts General Hospital Cardiovascular Research Center (CVRC) and Center for Genomic Medicine (CGM) and Broad Institute of Harvard & MIT has a unique post-doctoral fellow position open for a highly qualified applicant interested in investigating the genetics and biology of cardiovascular diseases using human genetics across diverse epidemiological cohorts, hospital-based biobanks, and within clinical trials.
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The Director, R&D Quality, GCP consults as necessary with quality and study teams on advanced GCP quality assurance oversight and management activities to ensure the highest level of compliance in Vertex CGT clinical trials are in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, clinical protocols and Vertex policies, procedures, and quality standards as set forth in the Quality Management System.
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The CICL provides cardiac imaging core laboratory services for large-scale national and international clinical trials. Minimum of 1 year of clinical experience in Echocardiographic lab in a hospital or outpatient set up.
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The Institute for Lung Health at Beth Israel Deaconess Medical Center, Harvard Medical School invites applications for a Clinical Research Coordinator to coordinate research activities, including clinical trials evaluating the impact of interventions on respiratory health and to support the research faculty and staff of the Institute.
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Completion of four (4) units of Clinical Pastoral Education. Completion of two (2) units of Clinical Pastoral Education. Communicates relevant patient information with other disciplines through the use of referral systems, chart entries and other mechanisms in the clinical setting.
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Job Description HI-Bio, Inc., a Biogen company, is seeking a Clinical Trial Specialist (CTS) or Senior CTS to assist in the execution of Clinical Trials. The successful candidate will be able to support the conduct of clinical trials with minimal guidance/supervision while ensuring alignment with GCP and HI-Bio’s SOPs. The Specialist provides a high level of administration, coordination and organizational support to the Clinical Study Lead and team members from all functions involved in assigned study(ies.
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The Clinical Trial Manager, Site Start-up will lead internal process improvements related to study start up activities to ensure clinical trials are executed with high quality standards in compliance with regulatory requirements, GCP, and company SOPs. This role is based in our Waltham, MA headquarters.
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Responsible for external outreach with KOLs and key clinical trial sites to provide feedback on study feasibility and study start up activities. Clinical Trial Initiation Manager will deliver high quality and timely global study start-up.
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The Clinical Trial Manager, Site Start-up will serve as an expert in study start-up practices by initiating efficient start-up activities and removing obstacles for study teams. Develop a Site Initiation Management Plan and coordinate regulatory and ethics committee submissions and perform day to day management of the study start up activities for clinical studies.
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Reporting to the Director/Senior Director of Clinical Operations, the Clinical Trial Manager, Site Start-up is accountable for leading, directing and overseeing end-to-end start-up, site initiation and site activation in collaboration with key stakeholders across multiple complex studies in a fast-paced environment.
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A minimum 5+ years of experience in Clinical Operations roles within the Pharmaceutical and/or Medical Device Industry, with heavy concentration within clinical trial management and monitoring.
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clinical trials jobs Title: social worker Company: Cincinnati Hospital Medical Center in Boston, MA
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