Tuba Bukhari

Manager, Clinical Trial Operations (Current)
Site Lead, Research Operations
Training Lead, Clinical Research
Clinical Research Coordinator (CRC)
Research Assistant (RA)

Promoted four times within DRI based on performance and leadership growth.

• Provide strategic and operational leadership across 80+ Phase II–IV clinical trials, ensuring quality, compliance, and delivery of key milestones.
• Act as Lead Sponsor representative for multiple clinical programs, overseeing CROs, monitors, and third-party vendors and ensuring clear communication and accountability.
• Oversee all aspects of study startup, including feasibility, regulatory submissions (FDA 1572, Health Canada NOL/QIU), IRB submissions, essential document management, and SIV-to-closeout oversight.
• Lead FDA audits and Health Canada inspections, preparing the site, managing documentation, supporting interviews, and contributing to CAPA development for successful outcomes.
• Direct clinical supply oversight, including labeling, storage, temperature monitoring, reconciliation, and distribution to ensure uninterrupted trial operations.
• Develop and deliver comprehensive training programs for CRCs and RAs, improving protocol adherence, quality, and operational consistency across the department.
• Support budget negotiations, clinical trial agreement (CTA) review, and operational planning with sponsors and CROs.
• Lead Investigator-Initiated Trial (IIT) development with a global cosmetic company:
  Designed the full clinical protocol for a dermatology-focused IIT study.
  Developed and negotiated the study contract and operational expectations.
  Built the data management platform (EDC/collection tools), ensuring data integrity, compliance, and user-friendly workflows.
  Provided end-to-end operational leadership, ensuring feasibility, regulatory readiness, and execution pathways for the IIT program.
• Chair weekly operations meetings and cross-functional discussions across regulatory, data management, safety, and investigator teams to ensure alignment and delivery of study objectives.

• Supported PI-led programs by assisting with protocol development and execution across multiple simultaneous studies.
• Conducted participant recruitment, consenting, data collection, REDCap entry, and preliminary data analysis.
• Collaborated with multidisciplinary teams to support operational study requirements and deliverables.