Advanced Certificate in Trial Site Operations

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The 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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AboutThisCourse

Throughout the course, learners engage with real-world case studies and scenarios, developing a deep understanding of the regulations, processes, and best practices that ensure successful clinical trials. Learners explore topics including site selection and initiation, study start-up, monitoring and close-out, data management, and pharmacovigilance. By completing this advanced certificate program, learners demonstrate their mastery of trial site operations, positioning themselves for career advancement and increased industry competitiveness. With a focus on practical application, this course empowers learners to make immediate, valuable contributions to their organizations.

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CourseDetails

• Regulatory Compliance in Clinical Trials: Understanding ICH-GCP, FDA, and EMA guidelines
• Site Selection and Feasibility Assessment: Identifying suitable trial sites and evaluating their capabilities
• Budgeting and Contract Management: Preparing and negotiating budgets, contracts, and service agreements
• Project Management in Clinical Trials: Planning, executing, and monitoring trial activities
• Site Initiation and Close-out: Preparing site study files, managing site initiation visits, and closing out sites
• Data Management and Quality Control: Ensuring data accuracy, completeness, and compliance
• Pharmacovigilance and Safety Monitoring: Managing adverse event reporting and safety monitoring
• Monitoring and Auditing: Conducting on-site and remote monitoring and preparing for audits
• Stakeholder Communication and Relationship Management: Engaging and collaborating with investigators, sites, and sponsors

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EntryRequirements

  • BasicUnderstandingSubject
  • ProficiencyEnglish
  • ComputerInternetAccess
  • BasicComputerSkills
  • DedicationCompleteCourse

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  • NotAccreditedRecognized
  • NotRegulatedAuthorized
  • ComplementaryFormalQualifications

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CourseFee

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FastTrack GBP £140
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AcceleratedLearningPath
  • ThreeFourHoursPerWeek
  • EarlyCertificateDelivery
  • OpenEnrollmentStartAnytime
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StandardMode GBP £90
CompleteInTwoMonths
FlexibleLearningPace
  • TwoThreeHoursPerWeek
  • RegularCertificateDelivery
  • OpenEnrollmentStartAnytime
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  • FullCourseAccess
  • DigitalCertificate
  • CourseMaterials
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ADVANCED CERTIFICATE IN TRIAL SITE OPERATIONS
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London College of Foreign Trade (LCFT)
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05 May 2025
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