Advanced Certificate in Trial Site Operations
-- ViewingNowThe Advanced Certificate in Trial Site Operations is a comprehensive course designed to equip learners with critical skills for success in the clinical trials industry. This certificate program focuses on the importance of trial site operations, an area of significant industry demand.
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โข Regulatory Compliance in Clinical Trials: Understanding ICH-GCP, FDA, and EMA guidelines
โข Site Selection and Feasibility Assessment: Identifying suitable trial sites and evaluating their capabilities
โข Budgeting and Contract Management: Preparing and negotiating budgets, contracts, and service agreements
โข Project Management in Clinical Trials: Planning, executing, and monitoring trial activities
โข Site Initiation and Close-out: Preparing site study files, managing site initiation visits, and closing out sites
โข Data Management and Quality Control: Ensuring data accuracy, completeness, and compliance
โข Pharmacovigilance and Safety Monitoring: Managing adverse event reporting and safety monitoring
โข Monitoring and Auditing: Conducting on-site and remote monitoring and preparing for audits
โข Stakeholder Communication and Relationship Management: Engaging and collaborating with investigators, sites, and sponsors
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