Senior Clinical Research Associate

About the role

The Sr. Clinical Research Associate (Sr. CRA) is responsible for overseeing the execution of clinical trials for in vitro diagnostic and medical devices. This role requires a strong background in clinical research, with experience in managing external sites and ensuring compliance with regulatory standards.

Responsibilities

• Set-up, initiation, execution, monitoring, and close-out of clinical trials at external sites
• Develop and maintain relationships with institutions, study investigators, internal stakeholders, and vendors
• Conduct independent study monitoring, including site coordination, investigational product accountability, and assessments of protocol deviations and adverse events
• Manage IRB submissions and all study regulatory documentation
• Contribute to study planning, including budget and contract negotiation, site identification and qualifications, and process improvement initiatives
• Create clinical templates such as informed consent forms and clinical monitoring plans

Requirements

• 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

Qualifications

• Ability to travel 20-70% within the US, including overnight(s)
• Experience with retrospective/prospective biological sample procurement
• Experience with electronic Trial Master Files and Clinical Trial Management Systems
• Experience with point-of-care research and knowledge of blood gas testing

Benefits

Within Danaher Diagnostics, we offer a comprehensive range of benefits including paid time off, medical/dental/vision insurance, and a 401(k) plan. Additionally, we provide a flexible remote work arrangement for eligible roles.