Carelle Tabet MSN-RN

-Managed TMF, eTMF and e-ISF activities across clinical research programs, ensuring completeness, accuracy and compliance with SOPs and ICH-GCP requirements. -Oversaw the clinical documentation lifecycle, including filing, review, quality control, reconciliation, archiving and study close-out. -Supported regulatory and ethics submissions, authority interactions, documentation preparation, translations and response management. -Provided project coordination and operational support.

- Coordinated pediatric oncology clinical trials across participating sites and national clinical research networks. - Coordinated and documented oncology network meetings, including minutes and follow-up activities. - Supported protocol development and treatment strategies for rare cancers. - Documented and reported Adverse Events (AEs) and Serious Adverse Events (SAEs) in accordance with study requirements. - Coordinated documentation and communication among investigators, sponsors, CRO partners and

-Coordinated multiple international vaccine clinical trials, including subject recruitment, staff training and clinical documentation. -Participated in investigator meetings for international trials involving pharmaceutical sponsors including Roche and GSK. -Ensured compliance with clinical trial protocols, ICH-GCP requirements and SOPs. -Developed SOPs and delivered protocol, GCP and informed-consent training. -Managed IRB submissions, responses to queries and quarterly study reports. -Developed patient re

- Delivered patient education, medication and IV administration, blood withdrawal and clinical procedures. - Supported hospital quality and accreditation activities related to JCI accreditation.