Clinical Study Operations Associate (Medtech)

TL;DR

Clinical Study Operations Associate (Medtech): Supporting the deployment of at-home EEG devices in clinical studies with an accent on study startup and site management. Focus on ensuring GCP/ICH compliance, training research sites, and monitoring project progress to ensure high-quality data collection.

Location: Swansea/Remote

Company

hirify.global is a leading at-home EEG platform utilizing AI algorithms to revolutionize precision medicine for brain-related disorders.

What you will do

• Collaborate with project teams to support study startup activities.
• Act as the primary point of contact for clinical research sites to ensure smooth operations.
• Provide training to sites on the use of Beacon's devices and study protocols.
• Monitor project progress, ensuring adherence to timelines and quality standards.
• Maintain strict compliance with GCP, ICH guidelines, and regulatory standards.
• Resolve operational issues promptly via Zendesk and Asana.

Requirements

• Experience in clinical project management or clinical operations roles.
• Strong organizational skills and ability to manage multiple responsibilities.
• Excellent written and verbal communication skills in English.
• Familiarity with GCP, ICH guidelines, and clinical research regulatory requirements.
• Meticulous attention to detail and a proactive mindset.

Culture & Benefits

• Robust asynchronous work practices ensuring a high-quality remote experience.
• Access to in-person office hubs in Boston, New York, and Paris.
• Culture driven by curiosity, simplicity, and deep empathy towards patients and colleagues.
• Inclusive environment that values diversity to build more robust systems.