Study Start-Up Clinical Research Associate

Job Description SummaryMonitors 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 the 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 DescriptionMajor Accountabilities:Assist the clinical research team in preparing safety reports for the investigator.Receive detailed instructions on all work.Report technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt.Distribute marketing samples (where applicable).Key Performance Indicators:Deliver customer satisfaction results for internal and external customers.Deliver clinical trials to quality standards and agreed timelines.Adhere 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.Skills Desired:Clinical Monitoring.Clinical Research.Clinical Study Reports.Clinical Trials.Databases.Problem Solving Skills.#J-18808-Ljbffr