[Remote] Senior Clinical Research Associate

Remote Full-time
Note: The job is a remote job and is open to candidates in USA. Danaher Corporation, through its subsidiary Leica Biosystems Imaging, Inc., is focused on advancing life sciences, diagnostics, and biotechnology. The Senior Clinical Research Associate will oversee clinical trials, ensuring compliance with FDA standards and maintaining relationships with stakeholders to drive successful trial execution.ResponsibilitiesOversee clinical study protocol execution at external sites, from start-up to close-out, ensuring timely data collection and compliance with FDA standards and Good Clinical Practice (GCP)Develop and maintain relationships with institutions, study investigators, internal stakeholders, and vendors to ensure successful trial execution, data integrity and adherence to project requirementsConduct independent study monitoring, including site coordination, investigational product accountability, and assessments of protocol deviations and/or adverse events, and drive clinical data quality which can include follow up on incomplete data entry and/or outstanding queriesManage IRB submissions and all study regulatory documentation to ensure Trial Master File is kept up to date and audit readyContribute to study planning including budget and contract negotiation and timeline forecasts, site identification and qualifications, and process improvement initiatives within the Global Clinical Affairs organization; as well as prepare study documents, including creating clinical templates, such as informed consent forms, clinical monitoring plan, etcSkillsBachelor's degree with 5+ years clinical research experience OR Master's degree with 3+ years clinical research experience OR Doctoral degree in field with clinical research experienceBasic knowledge of regulatory requirements and Good Clinical Practice for in vitro diagnostic and medical device productsPrevious experience with managing clinical research sites and monitoring clinical study dataGood technical background to understand and communicate current and new technologiesAbility to work on multiple projects simultaneouslyAbility to travel 20-70%– including overnight(s), within the US. Travel may be up to 70% during project initiation periodsRetrospective/prospective biological sample procurementExperience with electronic Trial Master Files and Clinical Trial Management SystemsPoint-of-care research and knowledge of blood gas testingBenefitsBonus/incentive payPaid time offMedical/dental/vision insurance401(k) to eligible employeesFlexible, remote working arrangements for eligible rolesRemote work arrangement in which you can work remotely from your homeCompany OverviewDanaher is a leading global life sciences and diagnostics innovator, committed to accelerating the power of science and technology to improve human health. It was founded in 1969, and is headquartered in Washington, District of Columbia, USA, with a workforce of 10001+ employees. Its website is https://www.danaher.com/.Company H1B SponsorshipDanaher Corporation has a track record of offering H1B sponsorships, with 7 in 2025, 4 in 2024, 3 in 2023, 1 in 2022, 2 in 2021, 1 in 2020. Please note that this does not guarantee sponsorship for this specific role.

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