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Under the direction of the Senior Director, this position collaborates and regularly meets with key stakeholders, including Clinical Research Disease Center Managers, CTO Associate Directors of Regulatory Operations, Regulatory Affairs, Network and Satellite Program, Project Management / Monitoring and Education and Training to promote excellence and streamlined collaboration in clinical research across all disease groups.
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Strong knowledge of biomarker technologies and methodologies, including genomics, proteomics, imaging, and flow cytometry, as applied to clinical research. Ph. D. or equivalent degree in Molecular Biology, Biochemistry, Pharmacology, or related field with a minimum of 8 years of relevant experience in clinical biomarker research within the biopharmaceutical industry.
$150,000 - $190,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Remain current on HNRCA fire and safety procedures, biosafety and radiation safety requirements, and MRU and HNRCA trainings related to best practices and safety procedures related to clinical research and protection of research participants.
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The Transforming Research and Clinical Knowledge in Traumatic Brain Injury Study (TRACK-TBI), comprised of 18 US Level 1 Trauma Centers, has accrued the largest and most comprehensive precision natural history study of TBI ever conducted in the US and enrolled more than 2900 patients with TBI across the age (0-100 years) and injury spectrum from concussion to coma, along with orthopedic and friend control groups.
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Demonstrates sound clinical judgment in assessing the patient's needs for long-term care, including evaluating the home and family situation, helping the patient and family to develop an in-home care plan, exploring alternatives to in-home care and arranging for placement if necessary.
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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modelling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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General Summary/Overview StatementThe Mass General Brigham (MGB) Digital Epic Platform Architect/Clinical Informatics Lead for Procedural Specialties is responsible for providing leadership and oversight of the build and maintenance of the procedural Epic applications including (but not limited to) Radiant, Cupid and OpTime/Anesthesia.
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In the Clinical Research Center (CRC), the Administrative Coordinator is responsible for providing administrative support to the Senior Investigator of Clinical, Behavioral & Outcomes Research, the CRC Nurse Manager and Manager of Administrative Services.
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The Clinical Data Analyst partners cross functionally to identify risk to data integrity throughout the data flow to drive quality collection for non-EDC data sources (fluid & tissue labs, digital, imaging, wearables) in Dyne's clinical studies.
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The Clinical Research Coordinator, Level 1 (CRC1) is a research professional who ensures oversight and compliance of both system-wide and local SHC clinical research activities. Reporting to the Hospital Administrator and to the Research Programs Office at SHC International Headquarters, the CRC1 provides support in accordance with SHC’s policies and procedures, SHC’s hospital regulations, the Code of Federal Regulation, and Good Clinical Practice.
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The Senior Research Regulatory Coordinator (RC) works under the direction of the CCI Executive Director, Research Operations Director and Principal Investigator(s) to complete the regulatory requirements of clinical research projects.
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The Respiratory Sales Specialist provides clinical and educational tools and programs to ensure successful understanding and application of the respiratory product line. The Respiratory Sales Specialist assists in the development and expansion of new and existing businesses through in-services, training programs, and their respiratory clinical expertise.
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If applicable to set up regular meeting with MSL (Medical Science Liaison) at LMA (Local Medical Affairs) who can support Clinical Operations at various steps (site qualification, site recruitment.
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Bachelor of Science (BS) or Arts (BA) college degree or equivalent clinical degree i.e., Registered Cardiovascular Invasive Specialist (RCIS), Certified Cardiology Technician, Registered nurse (RN) or Nurse Practitioner (NP), Transcatheter Cardiovascular Surgical/Scrub technician, Physician Assistant (PA.
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Experience in rare disease, pediatric, diabetes, renal or kidney and/or complex clinical trials highly preferred. Independently manage interactions with clinical monitors, data management, safety, regulatory, pharmaceutical science, QA team members etc., both internally and externally including our CRO Partners, to ensure ongoing performance alignment.
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Title: clinical in Somerville, MA
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