Clinical Research Associate

• Feb 2022 - Present

Clinical Trial Coordinator

• Jun 2017 - Jul 2019

• Phase III clinical trial entry in multiple software.• Maintaining electronic records for multicenter INPOG-Hodgkin Lymphoma and Acute Myeloid Leukemia clinical trials.• Experienced and established steady line of communication with patients for informed consent.• Responsible for tracking and supervising the enrolled participants of the trial and estimating volume of its data.• Updated and maintained of all clinical trial data including events, lab and radiology reports including follow up. • Accounted all regulatory trial documents including consent forms, randomization chart.• Collected data for retrospective study and for academic trials, through collaboration with interdepartmental administrator.• Assisted regulatory submission to SAC (Site Appraisal Committee) approval, ethics approval, trial agreements, CTRI (Clinical Trial Registration-India) application. • Maintained trial case records with labeling of case records with unique trial number. • Reported to SAE (Serious Adverse Effect) to ethics and DSMB (Data and Safety Monitoring Board) in the fixed time schedule.• Certified all records ready for surprise checks by ethics committee and external regulatory agencies, third party checks as well. • Verified proper storage of trial drugs in accordance to the industry standards/MSDS in close coordination with the relevant agencies. Show less

Data Manager

• Jun 2016 - Jun 2017

• Develops the electronic case report form (eCRF) specifications (including data capture screens and edit check specifications) needed to build a study-specific clinical database/electronic data capture (EDC) system.• Programs and maintains the clinical database.• In control for the development of eCRF completion and other material.• Develops data transfer contracts and specifications with sponsors providing external data (e.g. test site results).• Conducts reconciliation between external data and data in the EDC system to ensure consistency, including reconciliation with sponsor safety databases for AE/SAE(adverse events/serious adverse events data) .• Provides support to study team in the development of external systems capturing clinical data, monitoring side effects.• Ensures ongoing data review/cleaning during study conduct and also during preparation for database lock/close.• Produces data listings and reports needed for data review by the principal invigilator.• Ensures that data management documentation is complete and up-to-date in the trial master file (TMF).• Responds to users requiring assistance with the electronic data base system.• Archives the clinical database and associated documents. Show less

Personal tutor

• Sep 2014 - Dec 2015