Senior Specialist, Study Training Compliance & DoA Matrix Management

• Study Training Compliance 
  • Monitor and manage clinical staff training completion across multiple studies, ensuring alignment with study-specific and mandatory compliance requirements. 
  • Verify training accuracy and appropriateness for assigned roles during study start-up and transition phases. 
  • Ensure training records are consistently complete, current, and compliant with ICH-GCP, SOPs, and sponsor documentation standards. 
  • Provide guidance to internal teams and site staff on training requirements and timelines. 
• Delegation of Authority (DOA) Matrix Coordination 
  • Lead coordination of DOA matrix setup, review, and updates in alignment with protocol milestones. 
  • Confirm training compliance and role alignment for delegated tasks; flag gaps for resolution before study activation. 
  • Serve as a point of contact for delegation matrix-related documentation during audits and monitoring visits. 
• eISF & Documentation Oversight 
  • Upload, maintain, and review essential staff training records and certificates within the electronic Investigator Site File (eISF) and other internal systems. 
  • Ensure audit-readiness of all training and delegation matrix documentation across assigned studies. 
  • Prepare for and support internal audits, sponsor inspections, and document request responses related to study training compliance. 
• Cross-Functional Support & Collaboration 
  • Collaborate with clinical teams and other internal stakeholders to ensure training and delegation readiness across all phases of study execution. 
  • Contribute to study-specific training plans and compliance tracking tools to improve visibility and standardization. 
  • Communicate proactively with internal staff, sponsors, and vendors to support compliance activities and escalate issues when necessary. 
  • Participate in meetings and provide subject matter input on training and DOA compliance operations. 
  • Identify and contribute to process improvement opportunities related to training workflows and delegation management. 
  • Assist with the creation and refinement of guidance materials, trackers, and internal SOPs. 
• Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. 

• Strong understanding of clinical research operations, training documentation, and the regulatory environment. 
• Advanced organizational and tracking skills with attention to detail and documentation accuracy. 
• Ability to manage multiple complex assignments with minimal oversight while meeting deadlines in a fast-paced setting. 
• Comfortable navigating and maintaining documentation across platforms such as Florence (eISF), Clinical Conductor, and other training systems. 
• Excellent communication and interpersonal skills; able to coordinate effectively with internal teams, site staff, vendors, and sponsors. 
• Skilled in identifying and addressing gaps in training documentation or delegation readiness. 
• Proficient in Microsoft Office (Excel, Word, Outlook, SharePoint); experience with compliance tracking databases and tools. 

Certifications/Licenses, Education, and Experience

• Minimum Education:
  • Bachelor’s degree in Life Sciences, Health Administration, Clinical Research, or a related field preferred. 
• Minimum Experience:
  • Minimum of 3–5 years of experience in a Central Support, Clinical Operations, or Clinical Research Compliance role, ideally within a regulated research environment. 
  • Proven success supporting or leading training compliance workflows, DOA matrix coordination, and documentation management across multiple clinical studies. 
  • Demonstrated ability to work within quality-driven systems and maintain audit-ready documentation across multiple trials. 
  • Familiarity with eISF systems (Florence), CTMS tools, and sponsor portals is strongly preferred.