Global Certificate in Drug Development Clinical Trial Coordination

• Introduction to Clinical Trial Coordination: Understanding the basics of clinical trial coordination, including key players, regulations, and goals.
• Study Design and Protocol Development: Designing clinical trials, creating protocols, and selecting appropriate endpoints.
• Site Selection and Management: Identifying and managing clinical trial sites, including investigator selection and site initiation.
• Regulatory Affairs and Compliance: Ensuring compliance with regulations, including FDA and ICH guidelines, and managing regulatory submissions.
• Data Management and Quality Control: Collecting, managing, and analyzing clinical trial data, and implementing quality control measures.
• Project Management and Budgeting: Planning and executing clinical trial projects, including budgeting, timeline management, and resource allocation.
• Ethics and Patient Safety: Ensuring ethical conduct and patient safety in clinical trials, including informed consent processes and adverse event reporting.
• Clinical Trial Monitoring and Auditing: Monitoring clinical trials for quality and compliance, and conducting audits to ensure data integrity.
• Communication and Reporting: Communicating clinical trial results to stakeholders, including regulatory agencies, investigators, and sponsors.