Study Start-Up Clinical Research Associate

hace 2 semanas

Xico, México Novartis A tiempo completo

**Summary**:- Monitors patient data and 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 & study-related information from source documents, research records, and site visits where applicable.May monitor study sites and audit facility selection.**About the Role**:**Major accountabilities**:- Assist the clinical research team in preparing safety reports document for Investiga -Normally receives detailed instructions on all work -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 and external customers -Delivery of Clinical Trials to quality standards and agreed timelines -Adherence to Novartis policy and guidelines and external regulations**Minimum Requirements**:**Work Experience**:- Fix-its/Turnarounds.- Project Management.- Operations Management and Execution.- Collaborating across boundaries.**Skills**:- Clinical Monitoring.- Clinical Research.- Clinical Study Reports.- Clinical Trials.- Databases.- Problem Solving Skills.**Languages**:- English.DivisionDevelopmentBusiness UnitInnovative MedicinesLocationMexicoSiteINSURGENTESCompany / Legal EntityMX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.Functional AreaResearch & DevelopmentJob TypeFull timeEmployment TypeRegularShift WorkNo**Accessibility and accommodation**:Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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