Clinical Research Associate

CRA - Clinical Research Associate - Caesarea

Radix Engineering is recruiting a CRA for a global medical device company located in Caesarea.

Job Description

The role involves responsibility for the monitoring and management of clinical research sites, ensuring compliance with the highest standards of data quality and regulation.

Key Responsibilities:

• Performing monitoring visits and generating site visit reports in accordance with the Monitoring Plan.
• Ensuring full compliance with the Investigational Plan, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements.
• Overseeing site performance by reviewing protocol deviations and addressing queries and action items.
• Managing and maintaining regulatory and essential documents and filing them in the Trial Master File (TMF).
• Conducting device and/or drug accountability.
• Training clinical research site staff on protocols, database systems, and study requirements.
• Promoting patient enrollment processes and maintaining effective working relationships with investigators and research coordinators.
• Collaborating with cross-functional teams to ensure study activities meet timelines and quality standards.

Job Requirements

• Bachelor’s or advanced degree in a scientific discipline.
• At least 2 years of experience in clinical research monitoring (CRA) – significant advantage for experience with cardiovascular medical devices.
• High proficiency in English (speaking and writing).
• In-depth knowledge of ICH-GCP guidelines, clinical regulation, and ISO 14155.
• Experience working with electronic systems such as EDC, eTMF, and CTMS.
• High organizational skills, attention to detail, and excellent interpersonal skills.
• Ability to work in a corporate environment with a "Hands-on" approach in small teams