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@nishathakur
Aspiring clinical research professional with a focus on operations.
I am a dedicated professional pursuing a career in clinical research operations, driven by a commitment to continuous learning and contributing to team success. My educational background includes a Master’s in Neuroscience and an Advanced Certification in Clinical Research and Pharmacovigilance, which have equipped me with a solid foundation in the clinical trial process and research methodologies.
Currently, I serve as a Regional Trial Assistant at Sun Pharmaceutical Industries, where I support clinical study teams in planning, executing, and closing global clinical trials. My role involves managing Trial Master File documentation, maintaining the Clinical Trial Management System, and facilitating communication across cross-functional teams. I have also gained valuable experience as a Clinical Research Coordinator intern, where I ensured the quality of study-related documents and assisted in developing standard operating procedures.
With a strong understanding of clinical trial processes and a passion for research, I am eager to contribute my skills and knowledge to a dynamic team that aligns with my professional goals.
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Work history, roles, and key accomplishments
Sun Pharmaceutical Industries PVT Ltd
Feb 2024 - Present (1 year 9 months)
Supported clinical study teams in the planning, execution, and close-out of global clinical trials in compliance with ICH-GCP and applicable regulatory guidelines. Performed remote monitoring activities for global studies, including site document review, follow-up tracking, and coordination with site staff.
Medanta- The Medicity
Oct 2023 - Jan 2024 (3 months)
Responsible for filling electronic Case Report Forms (E-CRF) and ensuring the quality of study-related documents. Assisted in the development and editing of Standard Operating Procedures (SOPs) and maintained records.
Medeor Hospital, Qutab
Oct 2022 - Oct 2023 (1 year)
Performed duties as an EEG Technician, contributing to patient diagnostics. Gained experience in operating EEG equipment and interpreting results.
Karnataka Institute of Medical Science, Hubli
Dec 2020 - Jan 2023 (2 years 1 month)
Worked as an EEG Technician on the PREVENT study, focusing on the prevention of epilepsy by reducing neonatal encephalopathy. Contributed to clinical research efforts by performing EEG procedures.
Degrees, certifications, and relevant coursework
Advanced Certification Course, Clinical Research and Pharmacovigilance
Completed an advanced certification course focusing on clinical research and pharmacovigilance. Gained expertise in the latest industry practices and regulatory guidelines.
Master's, Neuroscience
Pursued a Master's degree in Neuroscience, gaining in-depth knowledge of the nervous system. Developed strong research and analytical skills applicable to clinical studies.
Bachelor's, Zoology Honours
Completed a Bachelor's degree with Honours in Zoology. Acquired foundational knowledge in biological sciences, which is essential for understanding clinical research.
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