Amrita Basu

Background

About Amrita Basu

Experienced in Clinical trials phases II, studies in adult, pediatric, adolescent and healthy volunteer population. Performed remote unblinded Site Initiation Visits (SIVs) and onsite unblinded Interim Monitoring Visits (IMVs) with 100% or reduced SDV and rSDR. Performed more than 40 onsite and remote PSVs. Maintained database, data collection and analysis, protocol development and prepared research ethics proposals and amendments. Prepared reports for projects. Developed informed consent documents and general health questionnaires for healthy human subjects. Participated in the recruitment and enrollment of healthy human subjects in Canada. Used different clinical and client specific systems for trial management, such as EDC, CTMS, eTMF, IVRS, IWRS. Recently I started working as Country Approval Specialist. Perform reviewing Informed Consent and Regulatory Submissions. I have 10 years of experience in the Academic Research Laboratory; gained expertise in several molecular biological, biochemical, and microbiological techniques. I am Certified Clinical Research Professional (CCRP, 2022) from SOCRA and Completed Vaccines Academy Certificate Program, 2022 in PPD. A comprehensive global development program, designed to ensure that candidates reach a high level of understanding and performance within the vaccine therapeutic area; program content is provided in a blended learning format with questions built into the modules to ensure learner understanding. Modules include Basic Immunology for Vaccines, COVID 19 Vaccines, Vaccine Types, General Vaccines, Vaccine Clinical Development, Trial Considerations for Vaccines, and an Operational Platform. I completed one-year certificate course in ‘Clinical Trials Data Management and Pharmacovigilance’ with Grade ‘A’ from Indian Biological Sciences & Research Institute Noida, India in 2018 and completed certificate course on “Introduction to the Principles and Practice of Clinical Research” in 2019-2020 from Office of Clinical Research, NIH. I am responsible with an adventurous mind; an open-minded persistent team worker - currently working as a Clinical Research Associate in a high–paced environment under tight deadlines and unique challenges.