Clinical Research Associate

Department: Quality, Clinical and Regulatory Affairs

Location: IceCure Medical, Caesarea

Reports to: Clinical Trial Manager

General:

The Clinical Research Associate (CRA) will be responsible for coordinating, managing, and documenting all clinical trial activities, while ensuring that the trial is conducted in compliance with regulatory requirements, ICH-GCP guidelines, internal SOPs, and applicable local laws. The position will serve as a key liaison between study sites, CROs, and regulatory bodies to ensure efficient and compliant execution of clinical research.

Knowledge/Educational requirements:

Ø Engineer, BSc, Nurse or a related scientific field.

Ø GCP training and CRA Certificate.

Ø 2+ years of experience as a clinical research associate in supporting global clinical trials.

Ø Solid understanding of the medical device industry, including relevant terminology, standards, and regulatory practices.

Ø Excellent verbal and written communication skills in English.

Ø Proficient computer skills: Microsoft Office Word, Excel, and PowerPoint.

Ø Willing and able to travel to the US (approximately once a quarter), with strong ability to manage travel logistics and schedules efficiently.

Key Responsibilities:

Ø Clinical Trial Documentation and Preparation - Contributing to the creation and review of clinical protocols and study SOPs (e.g., Monitoring Plan, Data Management Plan, etc.). Creating and maintaining essential trial documents including but not limited to ICF, CRF design, source document templates, protocol deviation reports, NTFs, training records and study logs. Establishing and organizing study files.

Ø Site Management and Support – Training the clinical site staff on study protocol, source documentation requirements, informed consent process, and accurate CRF completion. Providing continuous support to ensure protocol adherence and proper documentation. Maintaining active communication with site staff and monitoring site performance on a daily basis and ensuring accurate documentation and tracking of screening, enrollment, and follow-up data.

Ø Study Monitoring and Oversight – Conducting and overseeing outsourced CRO activities. Coordinating all monitoring visits (on-site and remote), including site qualification, initiation, interim, and closeout visits. Performing remote reviews of essential documents, data cleaning, and visit documentation. Supporting query resolution, eligibility review, informed consent compliance, and source data verification (SDV). Maintaining ongoing communication with outsourced CRA and preparing missing data lists prior to monitoring visits. Ensuring oversight and quality of all monitoring activities.

Ø Regulatory and Ethics Committee (EC/IRB) Communication - Preparing and submitting documentation for IRB submissions, continuing review reports, protocol amendments, and safety reports. Tracking approval statuses and ensuring timely renewals and submissions.

Ø Trial Master File and Documentation Management - Maintaining up-to-date and inspection-ready Trial Master File (TMF) and Site Regulatory Binders. Tracking and reconciling essential documents throughout the trial.

Ø Data Management - Collecting, validating, and preparing data for statistical analysis and regulatory submission. Working with data management teams to resolve discrepancies and clean data efficiently.

Ø Logistics Coordination – Overseeing the ordering and tracking of the investigational products and trial-related materials.

Ø Study Budget and Payment Tracking – Tracking site-level payments in alignment with clinical trial agreements and visit schedules.

Ø Compliance and Quality Assurance – Identifying and reporting protocol deviations, serious adverse events (SAEs), adverse device effects (ADEs), and ethical issues in a timely manner, and participating in internal and external audits and inspections as needed.

Ø Insurance and Legal Coordination – Monitoring and maintaining valid clinical trial insurance coverage throughout the study duration.

Ø Complaint Handling and Reporting - Documenting and reporting any study-related or device-related customer complaints to the Clinical Trial Manager according to internal procedures.

Ø Supporting the clinical team projects as needed.