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.

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, 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 queries
• Manage IRB submissions and all study regulatory documentation to ensure Trial Master File is kept up to date and audit ready
• Contribute 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, etc

Skills

• Bachelor'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 experience
• Basic knowledge of regulatory requirements and Good Clinical Practice for in vitro diagnostic and medical device products
• Previous experience with 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
• Ability to travel 20-70%– including overnight(s), within the US. Travel may be up to 70% during project initiation periods
• Retrospective/prospective biological sample procurement
• Experience with electronic Trial Master Files and Clinical Trial Management Systems
• Point-of-care research and knowledge of blood gas testing

Benefits

• Bonus/incentive pay
• Paid time off
• Medical/dental/vision insurance
• 401(k) to eligible employees
• Flexible, remote working arrangements for eligible roles
• Remote work arrangement in which you can work remotely from your home

Company Overview

Company H1B Sponsorship