Subject Matter Expert (SME) – Clinical Research Coordinator/Manager Certification
We are seeking a highly analytical and forward-thinking Subject Matter Expert to develop, test, and maintain high-quality online course content for a 16-course Microsoft Certification Curriculum for Clinical Research Coordinator/Manager. The ideal candidate possesses deep expertise in clinical research processes, regulations, and best practices, combined with proficiency in Microsoft productivity and collaboration tools for research operations.
This role requires the SME to:
• Complete all activities as a learner and provide improvement recommendations
• Validate clinical research accuracy and regulatory compliance content
• Ensure Microsoft tool integration is realistic and valuable for research workflows
• Provide Atlas commentary with specific, actionable feedback
• Advise on assessment design including AI-graded rubrics and summative formats
• Coordinate with the Healthcare IT/Cloud SME for technical validation
• Uphold Governance & Brand Guardrails for responsible content
Responsibilities
Discovery & Validation
• Review and validate existing Job Task Analysis (JTA) documents to ensure alignment between course content and industry requirements for Clinical Research Coordinators and Managers
• Assess and validate the relevance of the Content Outline to ensure focus on essential areas such as clinical trial management, regulatory compliance, patient safety, and Microsoft tool integration for research operations
• Assess and validate Coursera's In-Demand Topic (IDT) framework
• Critically review and validate the Coursera-created Content Outline, ensuring cohesion and relevance to learning objectives
• Validate that Microsoft product integration is realistic and valuable for clinical research workflows
Content Development & AI Validation
• Develop instructional materials, including case studies, concept guides, and interactive scripts that cover key topics such as Good Clinical Practice (GCP), study design, data collection methods, and Microsoft tools for research management
• Ensure that materials are comprehensive and reflect current trends and challenges in clinical research, including digital transformation and AI-assisted documentation
• Develop content showing how Microsoft 365, Teams, SharePoint, and Power Platform enhance clinical research workflows:
• SharePoint: Trial Master File organization, document version control, regulatory file management
• Teams: Study team communication, site coordination, sponsor collaboration
• Planner/Project: Study milestones, task assignments, timeline management
• Power Automate: Protocol deviation workflows, approval routing, notification automation
• Power Apps: Custom data collection forms, site visit checklists
• Excel: Enrollment tracking, study metrics, data analysis
• Word + Copilot: Protocol drafting, consent form development, correspondence
• Create scenarios demonstrating Copilot use for research documentation, communication, and analysis
• Review and validate content for "add-on" modules, including career resource materials such as "Day-in-the-Life" videos
• Design and validate practical activities and labs that provide students with hands-on experiences, including Microsoft platform exercises for study management
Activity Testing & Validation
• Complete all activities as if you are a learner, following instructions exactly as written
• Obtain and maintain access to Microsoft 365, Teams, SharePoint, Power Platform, and Copilot test environments
• Execute each step in activities; document any failures, confusion, or friction points
• Verify that stated completion times are accurate for target learner level
• Validate that UI references (Microsoft portal menus, buttons, workflows) are current
• Test Power Automate flows and Power Apps forms for functionality
• Verify Teams and SharePoint configurations work as described
• Test document collaboration and co-authoring scenarios
Atlas (Course Blueprint/Storyboard) Commentary & Improvement Recommendations
• Provide specific, actionable improvement recommendations in Atlas comments—not just gap identification
• Suggest alternative approaches where clinical research workflows could be better demonstrated
• Recommend additions that increase real-world applicability for research coordinators
• Comment on whether content difficulty matches the Intermediate level designation
• Flag any content affected by Microsoft platform updates or regulatory changes
• Identify opportunities to strengthen Microsoft tool integration
Multimedia &a
This role requires the SME to:
• Complete all activities as a learner and provide improvement recommendations
• Validate clinical research accuracy and regulatory compliance content
• Ensure Microsoft tool integration is realistic and valuable for research workflows
• Provide Atlas commentary with specific, actionable feedback
• Advise on assessment design including AI-graded rubrics and summative formats
• Coordinate with the Healthcare IT/Cloud SME for technical validation
• Uphold Governance & Brand Guardrails for responsible content
Responsibilities
Discovery & Validation
• Review and validate existing Job Task Analysis (JTA) documents to ensure alignment between course content and industry requirements for Clinical Research Coordinators and Managers
• Assess and validate the relevance of the Content Outline to ensure focus on essential areas such as clinical trial management, regulatory compliance, patient safety, and Microsoft tool integration for research operations
• Assess and validate Coursera's In-Demand Topic (IDT) framework
• Critically review and validate the Coursera-created Content Outline, ensuring cohesion and relevance to learning objectives
• Validate that Microsoft product integration is realistic and valuable for clinical research workflows
Content Development & AI Validation
• Develop instructional materials, including case studies, concept guides, and interactive scripts that cover key topics such as Good Clinical Practice (GCP), study design, data collection methods, and Microsoft tools for research management
• Ensure that materials are comprehensive and reflect current trends and challenges in clinical research, including digital transformation and AI-assisted documentation
• Develop content showing how Microsoft 365, Teams, SharePoint, and Power Platform enhance clinical research workflows:
• SharePoint: Trial Master File organization, document version control, regulatory file management
• Teams: Study team communication, site coordination, sponsor collaboration
• Planner/Project: Study milestones, task assignments, timeline management
• Power Automate: Protocol deviation workflows, approval routing, notification automation
• Power Apps: Custom data collection forms, site visit checklists
• Excel: Enrollment tracking, study metrics, data analysis
• Word + Copilot: Protocol drafting, consent form development, correspondence
• Create scenarios demonstrating Copilot use for research documentation, communication, and analysis
• Review and validate content for "add-on" modules, including career resource materials such as "Day-in-the-Life" videos
• Design and validate practical activities and labs that provide students with hands-on experiences, including Microsoft platform exercises for study management
Activity Testing & Validation
• Complete all activities as if you are a learner, following instructions exactly as written
• Obtain and maintain access to Microsoft 365, Teams, SharePoint, Power Platform, and Copilot test environments
• Execute each step in activities; document any failures, confusion, or friction points
• Verify that stated completion times are accurate for target learner level
• Validate that UI references (Microsoft portal menus, buttons, workflows) are current
• Test Power Automate flows and Power Apps forms for functionality
• Verify Teams and SharePoint configurations work as described
• Test document collaboration and co-authoring scenarios
Atlas (Course Blueprint/Storyboard) Commentary & Improvement Recommendations
• Provide specific, actionable improvement recommendations in Atlas comments—not just gap identification
• Suggest alternative approaches where clinical research workflows could be better demonstrated
• Recommend additions that increase real-world applicability for research coordinators
• Comment on whether content difficulty matches the Intermediate level designation
• Flag any content affected by Microsoft platform updates or regulatory changes
• Identify opportunities to strengthen Microsoft tool integration
Multimedia &a