Amrita Basu, M.Sc, Ph.D, CCRP (She/Her)

Clinical Research Associate with 4 years of experience in the industrial setting and 4 years of clinical research experience in the academic setting. More than 8 years of experience in the Academic Research Laboratory. As CRA Worked on 4 clinical trials in Dermatology, Virology, Vaccine, and Genetics and worked as an unblinded CRA with the Nervous system indications. Performed all types of monitoring visits (Site selection, site initiation, Interim visits and close out) in onsite and remote settings with 100% or reduced SDV for phase I, II, and III. Coordinated assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs. Develop collaborative relationships with investigative sites and client company personnel. Used different clinical and client specific systems for trial management, such as EDC, CTMS, IVRS, IWRS, eDiaries. Participated in 2 sponsor audits and supported investigative site in preparation. Worked in Risk based monitoring and 360 monitoring set up. Worked as a Regulatory Specialist for 6 months, reviewed Informed Consent and Regulatory submissions. In the academic setting, I worked on 2 Clinical trials in Hematology/Oncology therapeutic area processing and banking clinical sample, maintained database, data collection and analysis, protocol development and prepared research ethics proposals and amendments. Developed informed consent documents and general health questionnaires for healthy human subjects. Participated in the recruitment and enrollment of healthy human subjects. 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. 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.