Niharika Raghavapuram

Experience

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  Yashoda Hospitals

  Aug 2015 - Jun 2017

  Clinical Pharmacist

  • Developed interventional strategies to maximize appropriate Antibiotic utilization and improvement in patient outcomes for Antimicrobial stewardship committee Infectious Diseases.• Implemented Cardiothoracic Antibiotic monitoring (Compliance rate increased to 98%)• Implemented Surgical Antibiotic Prophylaxis Monitoring • Inpatient antibiotic monitoring active interventions and evaluations resulted in cost savings of eight million three hundred fifty-four thousand dollars • Implementation of preauthorization before the approval of ceftazidime-avibactam (Xpert carba detection) to all the physicians to detect colonization with Carbapenems producing organisms and prevent Carbapenem resistant Enterobacteriaceae.• Implemented Antibiotic Lock Therapy, Therapeutic drug monitoring of Vancomycin for gram-positive organisms• Antibiotic policies implemented Show less

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  Jeevan Scientific Technology Limited

  Aug 2017 - Sept 2018

  Clinical Research Associate/Medical writer

  Experienced in Oncology, Rheumatology (Biosimilar) studies Provided scientific knowledge to develop new business pitches and proposals and established confidentiality agreements with the vendors in the clinical studyDeveloped various trackers to monitor several stages of clinical studies, Identified and determined Site feasibilities, Site selection, Site initiation, Site monitoring and closeouts based on the protocol requirementsConducted clinical study-related activities like IEC/IRB dossiers, Approvals, Inpatient visits, source data verification, Informed consent verification, AE/SAE review, etc. Reviewed eCRF/CRF taking into consideration of patient medical data Point of contact for investigator(s)/site personnel on enquiries about patient selection criteria for ongoing studies, Developed manuals and monitored Informed Consent process, Dosing, PK sampling, Vitals assessment, etc.Projects:Clinical Trial Monitoring: •Adalimumab Phase 3 Study, Capecitabine: BA/BE Phase 1 Study, Varicella Vaccine: Phase 4 Study Medical Writing: Insulin Phase 3 Study, Etanercept, Imatinumab, Mercaptopurine, Nitazoxanide, Alopecia, Covid studies. Clinical Study Report: Experienced in CSR writing concordance to New drug CT rules (2019) CDSCO, Varicella Vaccine: Phase 4 Study Show less

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  Abbott

  Oct 2018 - Dec 2019

  Clinical Research Associate

  Worked for preclinical phase 2,3 neurology studies and medical devices

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  Eisai US

  Dec 2019 - Dec 2021

  Senior Clinical Research Associate

  worked on Preclinical phase 1,2,3 clinical trials in therapeutic areas Oncology, Cardiovascular, Immunology and Inflammation, Infectious disease, Respiratory

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  AstraZeneca

  Jan 2022 - now

  Senior Clinical Research Associate

  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 Show less