[Remote] Senior Clinical Research Associate

Note: The job is a remote job and is open to candidates in USA. Leica Biosystems, part of Danaher, is focused on accelerating innovation in life sciences and diagnostics. The Senior Clinical Research Associate will oversee clinical trials, ensuring compliance and data integrity while managing relationships with external sites and stakeholders.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 0-2 years 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 OverviewLeica Biosystems develops laboratory workflow solutions for anatomic pathology involved in the advancement of cancer diagnostics. It is a sub-organization of Danaher. It was founded in 1989, and is headquartered in Nußloch, Baden-Wurttemberg, DEU, with a workforce of 1001-5000 employees. Its website is http://www.leicabiosystems.com/.Company H1B SponsorshipLeica Biosystems has a track record of offering H1B sponsorships, with 1 in 2026, 3 in 2025, 3 in 2024, 1 in 2023, 7 in 2022, 3 in 2021, 1 in 2020. Please note that this does not guarantee sponsorship for this specific role.