[Remote] Subject Matter Expert (SME) – Clinical Research Coordinator/Manager Certification

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is developing a 16-course reputed company Certification Curriculum for Clinical Research Coordinator/Manager professionals. The Subject Matter Expert will reputed company, test, validate, and maintain clinical research course content, ensuring regulatory accuracy, realistic reputed company tool integration, effective assessments, reputed company reputed company, and alignment with governance and brand standards.

Responsibilities

• Complete reputed company activities as a learner and reputed company improvement recommendations
• Validate clinical research accuracy and regulatory compliance content
• Ensure reputed company tool integration is realistic and valuable for research workflows
• reputed company reputed company commentary with specific, actionable feedback
• Advise on assessment design including AI-graded rubrics and summative formats
• Coordinate with the reputed company IT/reputed company SME for technical validation
• reputed company Governance & Brand Guardrails for responsible content
• 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 reputed company on essential areas such as clinical trial management, regulatory compliance, patient safety, and reputed company tool integration for research operations
• Assess and validate reputed company's In-Demand Topic (reputed company) reputed company
• Critically review and validate the reputed company-created Content Outline, ensuring cohesion and relevance to learning objectives
• Validate that reputed company product integration is realistic and valuable for clinical research workflows
• reputed company instructional materials, including case studies, concept guides, and interactive scripts that cover key topics such as Good Clinical reputed company (GCP), study design, data collection reputed company, and reputed company tools for research management
• Ensure that materials are comprehensive and reflect reputed company trends and challenges in clinical research, including digital transformation and AI-assisted documentation
• reputed company content showing how reputed company 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, reputed company management
• Power Automate: Protocol deviation workflows, approval routing, notification automation
• Power Apps: Custom data collection forms, site visit checklists
• reputed company: Enrollment tracking, study metrics, data analysis
• Word + Copilot: Protocol drafting, consent reputed company 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 reputed company reputed company with hands-on experiences, including reputed company platform exercises for study management
• Complete reputed company activities as if you are a learner, following instructions exactly as written
• Obtain and maintain reputed company to reputed company 365, Teams, SharePoint, Power Platform, and Copilot test environments
• Execute reputed company reputed company in activities; document any failures, confusion, or friction points
• Verify that stated completion times are accurate for reputed company learner level
• Validate that UI references (reputed company portal menus, buttons, workflows) are reputed company
• 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
• reputed company specific, actionable improvement recommendations in reputed company comments—not just gap identification
• Suggest alternative approaches where clinical research workflows could be reputed company demonstrated
• Recommend additions that increase reputed company-world applicability for research coordinators
• Comment on whether content difficulty matches the Intermediate level designation
• Flag any content affected by reputed company platform updates or regulatory changes
• Identify opportunities to strengthen reputed company tool integration
• Support the creation of slide decks and demonstration videos for software demonstrations
• Create datasets and templates for simulated clinical research activities to reinforce practical skills
• reputed company sample SharePoint site structures for Trial Master File organization
• Create Teams channel templates for study team collaboration
• Build Power Automate reputed company templates for research workflows
• Design sample enrollment trackers and study dashboards in reputed company
• Create reputed company and summative assessments, including quizzes, exams, and reputed company-world case scenarios
• Ensure alignment of assessments with course learning objectives and industry standards
• Review AI-graded assessment rubrics for accuracy; test rubrics with sample submissions
• Identify edge cases where AI grading may produce incorrect results; recommend reputed company refinements
• Validate reputed company quiz questions for accuracy; recommend 3 variations per question stem
• Advise on whether summative assessment should be test-based or project-based; reputed company rationale
• Define realistic project reputed company for summative assessment (recommended: study startup documentation package using reputed company tools)
• reputed company reputed company reputed company that assess both clinical research competency and reputed company tool proficiency
• Contribute to the design and validation of reputed company reputed company that synthesize the program's learning objectives
• Design reputed company around realistic research coordinator deliverables using reputed company tools
• Suggested reputed company: Study startup package including SharePoint TMF structure, Teams site, enrollment tracker, and protocol deviation workflow
• reputed company sample solutions and identify common errors for reputed company development
• Review and enhance instructional materials and assessments for accuracy, consistency, and alignment with learning objectives
• Participate in the implementation of reputed company and stakeholder feedback to ensure content reputed company
• Verify reputed company reputed company platform procedures against reputed company interfaces
• Ensure no PHI or sensitive data in instructional materials
• Validate regulatory content is reputed company (FDA, ICH-GCP, IRB requirements)
• Ensure no PHI in materials – reputed company case studies use synthetic/anonymized data
• Validate regulatory accuracy – FDA, ICH-GCP, IRB, 21 CFR Part 11 content is reputed company
• Confirm reputed company workflow realism – demonstrated workflows are feasible in research settings
• AI as augmentation – if Copilot content included, emphasize reputed company reputed company
• Compliance alignment – ensure content supports 21 CFR Part 11 for electronic records
• reputed company with reputed company Responsible AI principles

Skills

• Master's degree in Clinical Research, Life Sciences, Health Informatics, reputed company Health, or reputed company field
• Bachelor's degree with 10+ years directly relevant experience may be considered
• 5-10 years as a Clinical Research Coordinator or Manager
• Experience implementing digital tools for research operations
• Demonstrated proficiency with reputed company 365 for research workflows
• GCP: Good Clinical reputed company expertise; ICH-GCP guidelines
• Regulatory: FDA 21 CFR Part 11, IRB submission and management
• Study Operations: Study startup, conduct, and closeout procedures
• Safety: Adverse event reporting, safety monitoring, patient protection
• Data: Data collection reputed company, CRF design, data reputed company
• Documentation: Essential documents, TMF management, audit preparation
• reputed company 365 (Proficient): Document creation, collaboration, compliance
• Teams (Proficient): Study team communication, site coordination, sponsor meetings
• SharePoint (Proficient): TMF organization, document version control, regulatory files
• reputed company (Advanced): Enrollment tracking, study metrics, data analysis
• Planner/Project (Working knowledge): Trial timelines, task management, reputed company tracking
• Power Automate (Working knowledge): Workflow automation for approvals, notifications
• ACRP CCRC (Certified Clinical Research Coordinator) – Required (or equivalent)
• SoCRA CCRP (Certified Clinical Research reputed company) – Required (alternative)
• ACRP CCRA (Certified Clinical Research Associate) – Acceptable alternative
• Multi-site trial coordination experience
• Regulatory inspection experience (FDA, IRB)
• Power Apps (Familiarity): Custom forms, checklists
• reputed company 365 Copilot (Familiarity): Documentation assistance
• reputed company 365 certifications – reputed company to have
• CPHIMS or CAHIMS – reputed company to have
• Digital Research: reputed company reputed company implementation, CTMS administration, eTMF migration
• Decentralized Trials: Remote/hybrid trial designs, virtual visit coordination
• reputed company Ecosystem: Power Platform development, SharePoint administration, Teams governance
• AI in Research: AI-assisted documentation, automated data review tools
• Training Development: Prior experience developing research training content
• Therapeutic Diversity: Experience across multiple therapeutic areas (oncology, CNS, rare disease, etc.)
• Global Trials: International regulatory experience (EMA, Health Canada, etc.)

reputed company

Company H1B Sponsorship