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Clinical Research Associate Ii Oncology
hace 3 meses
.Clinical Research Associate II Oncology - FSP Team - Madrid page is loaded Clinical Research Associate II Oncology - FSP Team - Madrid Apply locations Madrid Spain time type Full time posted on Posted Yesterday job requisition id 2426435 As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.Summary of Responsibilities:Site management responsibility for clinical studies according to Fortrea' s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records.Conducts site monitoring responsibilities for clinical trials according to Fortrea' s Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.Prepares and implements project plans related to Clinical Monitoring responsibilities.Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements.Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems.Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial.Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements.Ensures adherence to global quality control and CRA performance metrics.Ensures audit readiness at site level.Acts in the project role of a Lead CRA as assignedGeneral On-Site Monitoring Responsibilities:Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study. Ensure the protection of study subjects or patients by performing eligibility review, verifying that screening, informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.Ensure the integrity of the source data reported by careful source document review. Monitor data for missing or implausible data.Ensure study data completeness, accuracy, consistency, and compliance; identify deficiencies, deviations and discrepancies, and initiate corrective action as required
