Clinical Trials Site Operations - Printable Version +- Nice1 Community Forum (https://talk.nice1.org) +-- Forum: Nice1 Community (https://talk.nice1.org/forumdisplay.php?fid=3) +--- Forum: Media (https://talk.nice1.org/forumdisplay.php?fid=9) +--- Thread: Clinical Trials Site Operations (/showthread.php?tid=1801)

Clinical Trials Site Operations - Courses2025 - 12-03-2025 Free Download Clinical Trials Site Operations Last updated 12/2025 MP4 | Video: h264, 1920x1080 | Audio: AAC, 44.1 KHz Language: English | Size: 6.08 GB | Duration: 7h 42m End-to-end site operations processes and best practices. What you'll learn Understand the purpose of clinical trials and comprehend drug development lifecycle Understand clinical trial design, study objectives and recognize study endpoints Understand end-to-end site operations processes and best practices Complete clinical trial site activities related to study planning, start-up, site activation, study execution and close out. Define the purpose and scope of site feasibility and site selection Describe the criteria sponsors and CROs use to select sites Evaluate the importance of patient population, investigator experience, infrastructure and regulatory readiness in site selection Prepare the site internal workflows before enrolling the first patient Ensure site readiness to manage investigational product and study biological samples Create a realistic plans to meet enrollment targets Understand the key components of study budgets, identify cost elements and negotiation strategies Recognize the roles and responsibilities of stakeholders in budget and contract activities Outline the ethical approval processes and apply best practices to ensure timely and quality submissions Ensure readiness of study supplies, system accesses and equipment Create source document templates Coordinate all operational elements required for study activation Identify the most common study vendors involved in trials and how to set up and manage vendor workflows Design site workflows and document internal processes Recognize the critical operational areas that support protocol compliance and data quality Understand patient pathways, develop and execute patient recruitment strategies Understand key patient management processes across trial stages Conduct informed consent ethically and accurately Prepare, execute and document study procedures Coordinate study visits and handle early discontinuations Manage Investigational Product tasks from receipt to return or destruction Identify, document, report and follow up on patient safety events Understand how to prepare and manage clinical trial biological samples Recognize source documents importance and apply best documentation practices Enter data accurately and timely in electronic data capture systems Prevent data entry errors and manage queries Handle protocol deviations and apply corrective and preventative action plans Identify core sections of study files and apply best practices in maintaining files audit ready Understand site's responsibilities in implementing protocol amendments Coordinate operational changes related to protocol amendments Prepare for sponsor monitoring visits and support action items resolution Understand the significance of database lock process in clinical trials Plan and manage data entry, query resolution and Investigator sign off tasks Identify actions required to prepare for and complete a site close out Understand the clinical trial payments process and support accurate financial reporting Explain the purpose of clinical trials risk management, conduct risk assessments and develop mitigation plans Define the scope of quality monitoring and Identify site performance indicators Integrate quality improvement measures into site daily clinical trial operations Explain the core Principal Investigator's responsibility, describe their oversight process and best practices Requirements Interest in the Clinical Research Industry Healthcare and Science Background Description The clinical research industry is complex: I've made it simple.Clinical trials involve strict regulations, detailed documentation, and countless moving parts. For new or growing sites, it can feel overwhelming.That's why I distilled my expertise and created the Clinical Trials Site Operations Training: a clear, practical, and supportive guide to help you understand how clinical trials actually work from start-up to close-out, and how to successfully manage them at the site level.This course breaks down the complexity of clinical research into manageable, easy-to-follow lessons, presented by someone who understand the challenges sites face, in a friendly, conversational tone and supported by real-life examples. Learn at your own pace, on your schedule. No jargon, no pressure.The goal is simple: demystify complex processes and empower staff with the knowledge needed to excel in their roles as Investigators, Study Coordinators, Research Nurses, Clinical Trials Pharmacists, Clinical Trials Assistants.Whether you are new to the field or want to strengthen your operational performance, this course will provide you with essential skills and knowledge to confidently manage studies in compliance with GCP and sponsor expectations.Here's what to expect:A friendly, conversational style: think of it as learning alongside a trusted colleague.Clear walk-through of a trial lifecycle: from feasibility and start-up, initiation to conduct and close-out.Site-Focused: Built specifically for staff managing (or wanting to manage) day-to-day clinical trial operations.Real-life workflows: this course offers a deep dive into site operations, giving you the skills and confidence needed to excel in clinical trial management.Resources: templates, checklists, workbooks, and prompts to help you apply what you learn in your own work environment.Flexible Delivery: Self-paced online modules.What You'll LearnAll activities involved in trial planning, start-up, site activation, study execution and close out.End-to-end site operations processes and best practices.Whether you're a recent grad eager to enter clinical research, someone transitioning careers, or just looking to sharpen your clinical trial operations understanding - this course offers a robust foundation, actionable insights and will provide you with essential skills and knowledge to confidently manage studies in compliance with GCP and sponsor expectations.You'll feel equipped, confident, and ready to take charge of a site clinical trial operations from day one.No prior knowledge of clinical research is required. Basic understanding of medical terminology is recommended. 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