Nida Firdous

• Lead full-cycle clinical trial operations from protocol development to study closeout across NIH-funded and PI/Sponsor-initiated trials.

• Manage project timelines, budgets, and resource allocation across multiple studies.

• Collaborate with regulatory teams for IRB, FDA/IDE submissions and amendments.

• Oversee CROs, central labs, and vendors; ensure SLAs and KPIs are met.

• Address protocol deviations, audit findings, and inspection readiness.

• Mentor junior CRAs, coordinators, and Student interns

• Facilitate collaboration across Clinical Ops, Data Management, QA, and Medical Writing.

• Monitor trial invoices and coordinate with finance for payment reconciliation.

• Develop SOPs and document management systems to streamline operations.

• Established protocol compliance and site reduction in deviation guidelines as per GCP standards

• Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
• Implemented patient recruitment strategies and managed visit schedules.
• Ensured real-time data entry and query resolution in EDC systems.
• Participated in site initiation, monitoring, and closeout visits.
• Provided ongoing protocol training and supported inspection readiness.
• Developed and maintained accurate and up-to-date case report forms and source documents.
• Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
• Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.

• Supported staff members in their daily tasks, reducing workload burden and allowing for increased focus on higher-priority assignments.
• Gained valuable experience working within a specific industry, applying learned concepts directly into relevant work situations.
• Sorted and organized files, spreadsheets, and reports.
• Gained hands-on experience in various software programs, increasing proficiency and expanding technical skill set.