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
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

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

Senior Clinical Research Associate

Key skills