Niharika Raghavapuram
Clinical Trial Management system| Electronic Trial Master File | Essential Documents| SAE Management | Site Monitoring | Global Regulatory strategies | Interacting with KOLs
- Role
- Senior Clinical Research Associate at AstraZeneca
- Location
- Columbus, IN, US
- LinkedIn followers
- 500 followers
About Niharika Raghavapuram
Mainly worked in US pharmaceutical companies sponsored trials and well versed with FDA…
Experience
Senior Clinical Research Associate
Jan 2022 — Present · NY, US
Informed Consent Processing & Documentation• Clinical Data Collection & Documentation• Site Monitoring/Management• IRB Submission• ICH-GCP & FDA Regulations & Guidelines• Protocol Development and medical writing • Electronic Trial Master File/Essential DocumentsPlanning/Monitoring/Executing/Reporting• Study Drug Accountability• Case Report Form & Electronic Data Capture• Serious Adverse Events Reporting• Lab Sample Processing/Shipping• Clinical Research Vendor Management• Clinical Trails – Site Head and manager
Education
Jawaharlal Nehru University
Doctor of Pharmacy - PharmD
Malla Reddy Hospitals
Internship
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