Senior Clinical Research Associate

Overview

The Sr. Clinical Research Associate is responsible for set-up, initiation, execution, monitoring and close-out of IVD and medical device clinical trials at external clinical research sites and/or laboratories, and should be able to independently train and manage external clinical research sites. This is a fully remote role within the United States reporting to the Manager, Clinical Site Operations in the Global Clinical Affairs organization.

What you'll do

• 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
• 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 the Trial Master File is kept up to date and audit ready
• Contribute to study planning, including budget and contract negotiation, timeline forecasts, and site identification and qualifications
• Contribute to 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

What you'll need

• 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 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

Nice to have

• Retrospective/prospective biological sample procurement experience
• Experience with electronic Trial Master Files and Clinical Trial Management Systems
• Demonstrated understanding of CLSI standards and their application to IVD clinical studies, including method comparison, precision/reproducibility, reference interval, specimen stability, clinical performance, and point-of-care evaluations

Details

• Fully remote within the United States
• Travel 20-70% within the US, including overnight stays; travel may be up to 70% during project initiation periods
• Eligible for bonus/incentive pay
• Annual salary range $103,000.00 - $130,000.00