Fatema Tayabali

Dedicated professional with 9 years of experience in Clinical Trial Operations. Proficient in coordinating study activities, ensuring compliance with regulatory requirements and maintaining thorough study documentation. Demonstrated ability to collaborate effectively with cross-functional teams, including PI's, Medical Monitors and clinical research coordinators, to drive successful outcomes.

Excellent at troubleshooting within high pressure clinical environments to confirm timelines are met and patient safety is prioritized.

Research Project Associate at MSKCC (2024-03 – Present)

• Coordinate the collection of 150 blood and bone marrow samples per month for various CAR-T timepoints: supporting successful scientific analysis on patient disease status throughout therapy.
• Identify barriers in enrolling cellular patients on a Center for International Blood and Marrow transplant research database study, improving consent discussion frequency by 50% from 2024 to present.
• Manage patient data and outpatient clinic requirement for 20+ patients enrolled on a CAR-T study,; collaborating with the PI on abstract submissions to different medical conferences.
• Submit all required reports, documentation, updates and tracking within required time frames including but not limited to protocol deviations, patient recruitment, clinic supply and study progress metrics.
• Support non-therapeutic biospecimen research activities and protocol-related operational workflows.
• Assist with patient management, research documentation, data collection, and coordination of biospecimen research activities.
• Collaborate with clinical and research teams to address biospecimen protocol questions and follow-up needs.
• Maintained accurate and inspection ready clinical trial documentation in accordance with GCP and regulatory requirements.

Clinical Research Specialist at MSKCC (2022-01 – 2024-03)

• Coordinated and performed research tasks for 100+ protocols open across regional sites.
• Acted as a main point of contact for patient and study management encompassing clinical trials; guaranteeing sponsor obligations were met and compliance with GCP, ICH and FDA guidelines
• Completed real time reconciliation of research assessments in CTMS; ensuring participant safety and timely adverse reporting to sponsors and IRB.
• Maintained GCP/FDA/IRB compliance by ensuring that the regulatory documents are current. This includes but is limited to, the collection and maintenance of the FDA form 1572, training and delegation logs, investigator certifications and timely submission of protocol related documents.
• Educated over 200 patients on the institution's genomic profiling and biospecimen banking research studies; enhancing the study of genetic abnormalities that underlie cancer and finding more targeted treatments.

Clinical Care Coordinator II at MSKCC regional sites (2017-06 – 2022-01)

• Selected by management and the MSK training team to assist with onboarding new Care Coordinators.
• Managed 40+ patient per day clinic in a fast-paced environment, limiting long wait times and maintaining a high-quality patient focused environment.
• Served as a liaison between the clinical team, the patient, and their families by clarifying treatment options and resolving any concerns or inquiries.
• Worked with Electronic Medical Record and health information systems including Epic and CIS.

BSc in Physiology and Pharmacology – Wolverhampton University (2005)