Clinical Research Associate

OncoHost is a technology company headquartered in Binyamina, Israel, and Cary, North Carolina, transforming the approach to precision medicine for improved patient outcomes. Our proprietary platform, PROphet^®, is a plasma-based proteomic pattern analysis tool whose initial offering in non-small cell lung cancer (NSCLC) uses a single blood sample to guide first-line immunotherapy decision-making.

Our mission is to improve the lives of patients worldwide, and it drives everything we do. We're confident that we can achieve our mission with the right team. We are looking for a Clinical Research Associate (CRA) to join our growing team.

The CRA is responsible for supervising OncoHost’s clinical trial sites to ensure proper conduct and documentation, as well as accuracy and competence of the clinical data in the EDC by performing source data verification with the site trial documents. This position is based in our Binyamina office, and the chosen candidate will report to OncoHost’s VP of Clinical Affairs.

Duties & Responsibilities

• Ensure the investigators and site study teams adhere to the clinical study protocol, applicable regulations, ICH/GCP guidelines, local policies, and the study’s standard operating procedures. 
• Act as the main contact person for the study sites, develop strong relationships with sites to drive performance and generate new business for the future.
• Participate in training activities related to the clinical trial.
• Monitor clinical trial progress according to the monitoring plan through the performance of monitoring visits regularly (remotely and on-site, both locally and abroad). Submit written reports of monitoring activities to the sites and VP of Clinical Affairs.
• Ensure clinical data is accurate and complete (source data verification) and ensure data query resolution is achieved promptly. 
• Coordinate ongoing and upcoming monitoring assignments as directed by the VP of Clinical Affairs. Ensure study-related documentation (TMF/ISF) is current and complete according to regulatory requirements.
• Proactively identify and ensure timely resolution of study-related issues and escalate as appropriate to the VP of Clinical Affairs.
• Coordinate logistics and administrative tasks related to the study (shipments, payments, study supply, meetings, etc.)
• Verify the integrity of regulatory documents, ethical submission documents, and maintenance of the Investigator's Site File (ISF) in compliance with Good Clinical Practice (GCP) guidelines and local regulatory standards.
• Support study tasks and projects according to known and approved timelines. 
• Prepare for and collaborate on activities associated with audits and regulatory inspections.
• Support other clinical activities as will be determined by the VP of Clinical Affairs. 

Qualifications & Requirements

• Bachelor’s degree in a related health profession or other relevant field
• Required: Previous monitoring experience
• Knowledge of ICH and GCP guidelines, and clinical trial study process
• CRA certificate
• Ability to travel to sites abroad (once a quarter) and locally (once a week)
• Ability to work effectively in a team as well as independently
• Ability to manage multiple projects simultaneously
• Excellent personal and verbal communication skills
• Fluent Hebrew and English
• Advantage: Experience in the oncology field