Clinical Research Associate

At Phagenesis, we are committed to transforming lives by eliminating the burden of neurogenic dysphagia. As we transform into a high-performing global organization, we’re looking for exceptional individuals who thrive in fast-paced, evolving environments, and bring a strong sense of ownership and urgency to their work. ​​​

Our vision is clear—make Phagenyx the standard of care in ICU and acute care settings—and we need ambitious, mission-aligned talent to help us get there. We put patients first, operate with courage and trust, and foster a culture that values innovation, accountability, and a challenger mindset. ​

Role Overview: The Clinical Research Associate is responsible for overseeing day-to-day operational aspects of assigned studies to ensure they are conducted in compliance with applicable regulatory requirements, study protocols, and company SOPs.

Key Responsibilities:

• Serve as the primary liaison for clinical sites, ensuring effective site management and communication.
• Conduct qualification, initiation, interim monitoring, and close-out visits according to the monitoring plan and applicable regulatory regulations.
• Verify that study data are collected, recorded, and reported accurately and in compliance with the protocol and Good Clinical Practice (GCP) guidelines.
• Identify and resolve site issues and protocol deviations in collaboration with the study team.
• Provide ongoing training and support to site staff to ensure adherence to study procedures and regulatory requirements.
• Maintain timely and complete monitoring documentation, including visit reports, follow-up letters, and tracking of action items.
• Assist with site selection, feasibility assessments, and contract/budget negotiations as needed.
• Participate in internal study team meetings and contribute to project planning and timeline management.
• Collaborate cross-functionally with data management, regulatory, safety, and other team members.
• Support audit and inspection readiness activities at sites and sponsor level.

Essential Experience:

• Bachelor’s degree in life sciences, nursing, or a related field.
• Minimum of 5 years of experience as a CRA, 2 years of medical device experience
• Demonstrated ability to manage clinical research activities at sites across multiple countries and regions outside the US
• Strong working knowledge of ICH-GCP, FDA regulations, and other relevant guidelines.
• Excellent written and verbal communication skills.
• Ability to work independently, manage multiple sites and priorities, and travel as required (50% travel expected).
• Proficiency with EDC systems and other clinical trial management tools.

Desirable Experience:

• Experience working with Class II and Class III medical devices
• Experience in a start-up company environment
• Experience working remotely from management team