Clinical Trials Site Operations

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.
New Grads eager to enter clinical research,Clinical Research Staff,Clinical Investigators,Healthcare Professionals interested in Clinical Research
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