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Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
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Our global Clinical Operations colleagues within our PPD clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts.
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Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
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Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability.
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Manages procedures and guidelines from the sponsor and/or monitoring environments (i.e. FSP client). Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency.
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Coordinate and conduct the operation of clinical trials as per GCP and ICH guidelines including participant recruitment; informed consent; continuous monitoring of protocol for compliance and patient safety; source document review; data entry; sponsor monitoring.
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In this role the Security Engineer supports efforts to minimize API security risk by discovering, managing, monitoring, and reporting on API security vulnerabilities while supporting the Automation of DevSecOps practice and pipeline.
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Performs and coordinates different aspects of the clinical monitoring and site management process. Assess investigational product through physical inventory and records review. Conducts monitoring tasks in accordance with the approved monitoring plan.
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Perform engineering calculations related to contaminant concentrations in soil, air, and/or groundwater; review operations and maintenance systems and data related to storm or wastewater systems, and assist with general civil aspects associated with monitoring, assessment, or remediation at sites in a variety of industries, including renewable energy projects.
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The Sr. QA Engineer is required to perform analysis and review of system requirements, estimations, peer reviews, test data determination and preparation, designing test strategy and test cases, executing test cases and monitoring and control of overall test activities, UAT and Production support and provide testing status.
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If you are a Nurse, Pharmacist, Site Coordinator, or you have other life science/pharma/CRO experience then please apply now to start your CRA career journey at one of the worlds leading global CROs! With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services.
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Work with FEMA and local governments on financial reconciliation; providing support on appeal activities to include research, analyses, cost estimation, review, writing decision paper and providing recommendations based upon historical data; and generating visual and written reports and briefings for reporting, tracking, performance monitoring, and other related purpose.
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Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. This opportunity is available in Madrid, Barcelona, Andalucia and Galicia.
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Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
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Comprehensive experience as a clinician in a healthcare environment (comparable to at least 3 years) that provides transferable knowledge, skills, and abilities to perform the job in a clinical research environment.
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