Clinical Research Associate- Israel

ART MEDICAL is a well-funded, medical startup developing cutting-edge technologies for ICU patients. Our smART+™ platform is an intelligent, sensor-based feeding system for critical care patients that aims to prevent life-threatening in-hospital complications such as ventilator-associated pneumonia, malnutrition, and acute kidney injury.
With the introduction of Nutrition Management 2.0™ to critical care patient scoring systems, the smART+™ platform monitors analyzes, and prevents malnutrition and gastric aspiration in real-time. By providing optimal nutritional care and achieving up to 100% feeding efficiency, the smART+™ platform improves the standard of care and helps ICU patients recover faster.

We are seeking a dedicated and detail-oriented CRA to join our team.
In this role, you will oversee and monitor clinical trials to ensure compliance with protocols, GCP and regulatory requirements.

Role & Responsibilities

• Ensure studies are conducted according to the protocol, ICH-GCP guidelines, local regulations, and ART MEDICAL Standard Operating Procedures (SOPs).
• Monitor the well-being and safety of trial participants, ensuring their rights are protected and clinical trial data is reliable.
• Perform on-site and remote monitoring activities, including initiation, interim, and close-out visits, and generate accurate and timely visit reports.
• Verify adherence to scheduled visit intervals and timely generation of visit reports.
• Prepare and maintain the regulatory binder for clinical trials.
• Assist in preparing the electronic Case Report Form (eCRF) for studies.
• Attend sites during study days to assist with equipment setup and patient connection to the system.
• Provide on-site support to clinical teams, resolving issues as they arise.
• Coordinate communication between the company and the study coordinator, acting as the primary point of contact.
• Contribute to the design and development of clinical trial protocols.
• Participate in data collection and analysis activities, including researching, summarizing findings, and drawing conclusions.
• Provide support for general tasks assigned by the Regulatory Affairs (RA) team.

Requirements

• Bachelor’s degree in life sciences, healthcare, or a related field (master’s preferred).
• At least 7 years of experience in clinical research, as a CRA, in medical devices.
• Strong knowledge of ICH-GCP, regulatory requirements, and clinical trial protocols.
• Excellent organizational and time-management skills.
• Strong communication and interpersonal skills, with the ability to coordinate across teams.
• Willingness to travel to clinical sites as needed.