Israel Job Openings
ART Medical
Clinical Research Associate - Israel
Netanya
November 26, 2024
ART MEDICAL is a well-funded, medical startup developing cutting-edge technologies for ICU patients. Our sm ART+™ 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 sm ART+™ 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 sm ART+™ 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.
With the introduction of Nutrition Management 2.0™ to critical care patient scoring systems, the sm ART+™ 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 sm ART+™ 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 (e CRF) 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.
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