Bengaluru, Karnataka, India
As a Clinical Research Associate at AstraZeneca, I contribute to Phase IV and Real-World Evidence studies across various therapeutic areas. My role involves site selection, initiation, monitoring, trial closeout, and ensuring compliance with ICH, GCP, and local regulations. I also oversee site management, regulatory documentation, and ethical submissions, maintaining high standards of clinical trial execution. I hold a Doctor of Pharmacy (PharmD) degree from Dr. MGR Medical University and bring hands-on experience from previous roles coordinating Phase IV clinical trials and supporting NABH certification processes for Institutional Review Board. My work reflects a commitment to advancing healthcare and ensuring excellence in research and regulatory practices.
Clinical Research responsibilities: Experienced over 07 years in Phase IV, Real World Evidence studies in various Therapeutic Areas. •Perform site selection, initiation, monitoring, Trial close out and retrieval of trial materials •Compile and ensure completeness of regulatory documents and ethical submission documentation and review study materials •Provide monitoring visits and site management for a variety of protocols, sites, and therapeutic areas •Responsible for ensuring that the study is done in accordance with documentation requirements, international guidelines such as ICH and GCP as well as relevant local regulations •Design the draft and execute the site clinical trial agreement/budget for designated studies •Review study subject safety information and informed consent and conduct source document verification for compliance and patient safety Publication responsibilities: •Experienced over 05 years in publications in various therapeutic areas •Coordinated more than 70 articles to get accepted/ published in reputed journals and congress •Experienced in handling DATAVISION/iEnvision platform over 05 years •Coordinate with external medical writers and internal stakeholders for timely delivery of projects •Coordinate with authors for their comments and confirmation on the final draft •Finalization of target journals •Aligning the article as per journal requirements, preparation of cover letter for submission •Submission of manuscript to the target journal •Applied knowledge in proofreading of articles
• Worked on Phase IV clinical trials with indication of Metastatic Breast Cancer, Prevention of Cancer Chemotherapy Induced Neutropenia, Advanced/Metastatic Epithelial Ovarian cancer, Everolimus Eluting Coronary Stent, Sirolimus Eluting Coronary Stent • Worked for NABH and received NABH certificate (June 2019) for ethics committee