Danaher Corporation
Danaher Corporation
Danaher Corporation ғылыми зерттеулерде, биотехнологияда және клиникалық сынақтарда қолданылатын өмір туралы ғылымдар мен диагностикалық технологияларды әзірлейді. Оның бизнес бағыттары академиялық мекемелерге, фармацевтикалық және биотехнологиялық компанияларға, сондай-ақ клиникалық зертханаларға аспаптар, бағдарламалық жасақтама, технологиялар мен қызметтер ұсынады. Компания биотехнологиялық құралдарға, диагностикалық платформаларға және өмір туралы ғылымдарға арналған басқа да өнімдерге назар аударады, қызметін Danaher бизнес жүйесі арқылы басқарады және технологиялық портфелін әрі клиенттермен қамту аясын кеңейтетін сатып алулар арқылы өседі.

Senior Clinical Research Associate, IVD and Medical Devices — Remote US

Lead clinical research activities for Danaher Diagnostics across in vitro diagnostic and medical device trials. Manage study sites, monitor data, and support compliance with FDA requirements and Good Clinical Practice.

Сипаттама

  • Establish, launch, conduct, monitor, and close out IVD and medical device trials at external research sites and laboratories.
  • Train and oversee external clinical research sites independently.
  • Manage protocol execution from study start-up through close-out, maintaining timely data collection and FDA and Good Clinical Practice compliance.
  • Build effective working relationships with institutions, investigators, internal partners, and vendors.
  • Perform independent study monitoring, including site coordination and investigational product accountability.
  • Evaluate protocol deviations and adverse events while advancing clinical data quality.
  • Resolve incomplete data entry and outstanding data queries.
  • Coordinate IRB submissions and maintain regulatory study records.
  • Maintain an accurate, audit-ready Trial Master File.
  • Support study planning, budget and contract negotiations, timeline forecasting, site identification and qualification, and process improvement.
  • Develop study documentation and clinical templates, including informed consent forms and clinical monitoring plans.

Талаптар

  • Bachelor’s degree and at least five years of clinical research experience, master’s degree and at least three years of clinical research experience, or a doctoral degree in a relevant field with clinical research experience.
  • Working knowledge of regulatory requirements and Good Clinical Practice for in vitro diagnostic and medical device products.
  • Experience managing clinical research sites and monitoring clinical study data.
  • Technical expertise sufficient to understand and communicate current and emerging technologies.
  • Ability to manage multiple projects concurrently.
  • Willingness to travel 20–70%, including overnight travel, within the United States.
  • Experience procuring retrospective or prospective biological samples is preferred.
  • Experience using electronic Trial Master Files and Clinical Trial Management Systems is preferred.
  • Understanding of CLSI standards and their application to IVD clinical studies is preferred.

Артықшылықтар

  • Health care program
  • Paid time off
  • Medical insurance
  • Dental insurance
  • Vision insurance
  • 401(k)
  • Bonus or incentive pay
  • Flexible remote work arrangements for eligible roles
  • Work-from-home arrangement

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