Clinical Research Associate I, Ii

Job Description Summary
-Monitors patient data & study-related information related to clinical study sites and clinical trial participation.. Ensures the investigator adheres to research protocols, regulatory requirements and good clinical practices and provides input into data validation plan. Provides timely and accurate monitoring of patient data and study-related information from source documents, research records, and site visits where applicable. May monitor study sites and audit facility selection.Job Description Major accountabilities: Conducts site selection for potential sites to evaluate their capabilities for conducting a clinical trial -Performs site Initiation Visit, ensures site personnel is fully trained on all trial related aspects -Applies company policies and procedures to resolve a variety of issues -Frequent internal company and external contacts.Represents organization on specific projects -Contributes to some cost center goals and objectives -Is the frontline liaison between Novartis and sites to ensure successful collaboration, site engagement and meeting Novartis expectation on milestone and deliveries -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)Key performance indicators: Deliver customer satisfaction results for internal & external customers -Delivery of Clinical Trials to quality standards and agreed timelines.Adherence to Novartis policy and guidelines and external regulationsMinimum Requirements: Work Experience: Operations Management and Execution.Representing the organization.Collaborating across boundaries.Project Management.Skills: Clinical Monitoring.Clinical Research.Clinical Study Reports.Clinical Trial Management Systems.Clinical Trials.Collaboration.Data Integrity.Decision Making Skills.Lifesciences.Languages : English.Skills Desired
Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Collaboration, Data Integrity, Decision Making Skills, Lifesciences
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