About this role

Oversee clinical study protocol execution at external sites
Ensure 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
Conduct independent study monitoring, including site coordination and investigational product accountability
Manage IRB submissions and all study regulatory documentation
Contribute to study planning including budget and contract negotiation

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

Senior Clinical Research Associate

Key skills