Clinical Research Associate (CRA)

About Scopio Labs

Scopio Labs is a fast-growing medical technology company transforming the fields of hematology and cell morphology analysis. As a team, we work to enable faster, earlier detection and diagnosis of blood-related diseases, so patients can start treatment sooner and have better outcomes. We are collaborative and global – and every individual at Scopio Labs is part of a life-saving mission.

About our technology

Scopio has developed a digital imaging platform using novel computational photography. Built on top of this breakthrough technology is Scopio’s clinical-grade AI that automatically analyzes blood samples at the highest resolution available and in minutes. Scopio Labs has secured FDA clearance for its Full-Field Peripheral Blood Smear Application and its technology is in commercial use at hospitals and labs in the US, Europe, and Israel.

We are looking for a Clinical Research Associate (CRA) to join our Compliance and Regulatory Affairs (RA) team. Scopio’s Compliance and RA team is responsible for the company’s clinical and regulatory activities, quality management systems, and for ensuring compliance with applicable standards.

The team plays a central role in both pre-market and post-market activities. The CRA will play an important role, working with clinical sites, ensuring successful management of clinical activities, and performing assigned monitoring activities throughout the clinical trial lifecycle.

Your responsibilities will include:

• Managing Scopio global clinical trials at multiple clinical sites, taking part in planning clinical studies, defining clinical protocols, and supporting regulatory documentation.
• Collaborating with multiple Scopio stakeholders to ensure successful, rigorous, and timely studies.
• Proactively managing clinical study processes and monitoring activities. Overseeing and supervising clinical operations to ensure activities are carried in accordance with applicable regulatory requirements and guidelines.
• Maintaining strong relationships with external experts to ensure effective execution of clinical studies and research projects.
• Taking part in defining and approving clinical study protocols and plans, IRB submission documents, CRFs, and clinical study reports.
• Facilitating team training per study protocols and supporting regulatory submission and documentation.

The ideal candidate will have:

• Relevant bachelor’s degree (Biotechnology Engineering, Biomedical, Life Science/Exact Science)
• 2+ years of experience managing clinical trials, in-vitro diagnostics-related (IVD) preferred
• Working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential
• GCP/CRA certification preferred
• Familiarity with medical device and IVD RA preferred
• Understanding of quality assurance processes and methodologies (ISO 13485:2016, ISO 9001:2015 or similar) preferred
• A collaborative attitude
• Independence and self-motivation
• Excellent communication skills (written and verbal)
• Strong attention to details
• English proficiency