לוח אפשרויות קריירה - הדרך החכמה להייטק

a global medical device device company is looking for CRA
Responsibilities
Conducts site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with state and federal regulations, guidelines and policies (MOH, CRF, GDPR ISO).
submit and conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol.
Communication with the medical site staff including coordinators, clinical research physicians and their site staff.
Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements.
Verification that the investigator is enrolling only eligible subjects.
Assessing the clinical research site's patient recruitment and retention success and offering suggestions for improvement.
Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
Ensures appropriate transmission of clinical case data to the data management centers. reviews case report queries and problems, and clarifies and/or obtains changes to data as appropriate.
Performs miscellaneous job-related duties as assigned

דרישות:
2+ years of experience as a Clinical Research Associate.
Current GCP certificate and current CRA certificate
Must have a minimum of a bachelor's degree in a health or science related field.
Outstanding communication skills. and must be detail-oriented and efficient in time management.
Strong interpersonal, written, and verbal communication skills within a matrixed team.
Experience working in a self-driven capacity, with a sense of urgency and limited oversight. A client-focused approach to work and flexible attitude with respect to assignments/new learning.
Knowledge of industrial standards as applied to good clinical practices.
Ability to develop and deliver both oral and written presentations in Hebrew and English.
Work experience in the medical field – will be an advantage