Sr. Clinical Research Associate

The Sr. Clinical Research Associate (Sr. CRA) is responsible for the setup, initiation, execution, monitoring, and close-out of IVD and medical device clinical trials at external clinical research sites and/or laboratories. The Sr. CRA should independently train and manage external clinical research sites. Responsibilities Oversee 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 requirements. Conduct independent study monitoring, including site coordination, investigational product accountability, assessments of protocol deviations and/or adverse events, and drive clinical data quality by following up on incomplete data entry and/or outstanding queries. Manage IRB submissions and all study regulatory documentation to keep the Trial Master File audit‑ready. Contribute to study planning including budget and contract negotiation, timeline forecasts, site identification and qualification, and process improvement initiatives within the Global Clinical Affairs organization; prepare study documents, including creating clinical templates such as informed consent forms and clinical monitoring plans. Qualifications Bachelor’s degree with 5+ years clinical research experience, OR Master’s degree with 3+ years clinical research experience, OR Doctoral degree with 0‑2 years clinical research experience. Basic knowledge of regulatory requirements and Good Clinical Practice for in‑vitro diagnostic and medical device products. Previous experience managing clinical research sites and monitoring clinical study data. Good technical background to understand and communicate current and new technologies. Ability to work on multiple projects simultaneously. Travel Requirements Ability to travel 20‑70%, including overnight(s), within the United States. Travel may be up to 70% during project initiation periods. Preferred Experience Retrospective or prospective biological sample procurement. Experience with electronic Trial Master File and Clinical Trial Management Systems. CLSI guidelines and Good Laboratory Practice (GLP). Benefits We offer a comprehensive benefits package including paid time off, medical/dental/vision insurance, 401(k) matching, and additional life, disability and health coverage options. Location The position will be fully remote within the United States. Compensation The annual salary range for this role is $103,000.00 – $130,000.00. This role is also eligible for bonus/incentive pay. The compensation package may be adjusted in the future. Legal Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here ( We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, or to receive other benefits and privileges of employment, please contact: View phone number on click.appcast.io or View email address on click.appcast.io. #J-18808-Ljbffr