Clinical Project Associate

To support ongoing clinical investigations, the full-time Clinical Project Associate will manage relationships with research sites, conduct monitoring visits, and ensure compliance with federal regulations while working remotely in the United States. Key responsibilities Assist in the development and review of study documents, ensuring compliance with FDA and OrganOx requirements Conduct on-site and remote monitoring visits, creating reports and following up on action items Provide training to site personnel on protocol requirements and data collection methods Required qualifications Bachelor's or Graduate degree in a life science, nursing, or other health-related disciplines 2 years of clinical research experience in the medical device or pharmaceutical industry Strong working knowledge of FDA regulations and ICH/GCP guidelines Current certification as a Certified Clinical Research Associate (CCRA) or Certified Clinical Research Professional (CCRP) is preferred Must have a valid US driver's license and be willing to travel 10% of the time