Clinical Research Associate on behalf of Sanofi for Neurology, Rare Diseases-Metabolic, Hematology and Immunology-Dermatology phase II-III trials

cFSP CRA 1 on behalf of AstraZeneca for Oncology and Respiratory phase III trials. - Performed site selection, initiation, monitoring and close-out visits, and maintained appropriate documentation.- Established regular lines of communication and administered protocol and related study training to assigned sites, including subject recruitment plans support.- Evaluated the quality and integrity of site practices, and participated in site audits – escalating quality issues as appropriate.- Managed progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.

Clinical Research Physician, Clinical Study Protocol Compliance Supervisor and Electronic Medical Records Configurator for Pfizer, Moderna, Medicago, and GSK immunology and vaccine phase II-III trials.- Ensured the quality and integrity of all study documents. Implemented quality control process and internal monitoring throughout the trial.- Configured and controlled the implementation of the Electronic Medical Records (eMR) system in accordance with the protocol, CRF, and sponsor directives, and adapted it to the internal organization of the site.

Clinical Research Physician, Clinical Study Protocol Compliance Supervisor and Electronic Medical Records Configurator for Pfizer, Moderna, Medicago, and GSK immunology and vaccine phase II-III trials.- Performed medical visits according to the stipulated requirements. Reviewed informed consent and screening documentation, and approved subjects for participation, enrollment, and randomization. Collected, updated, and managed relevant data, including elegibility criteria, adverse events (AEs)/serious adverse events (SAEs), queries, action items, patient logs, clinical records, etc.

- Implemented and monitored public health system projects. Collected and analyzed data to evaluate the effectiveness and to identify areas for improvement.- Provided training and presented project status to stakeholders, including government officials, key opinion leaders, and medical authorities.

- Provided primary and emergency healthcare during COVID-19 pandemic at health and vaccination units.