プロフィール詳細

プロジェクトを作成

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Vrushali P.に依頼

India

Freelance Clinical Research and Regulatory Affairs Professional Medical Writing, Documentation

プロフィール概要

I’m a highly motivated and certified Clinical Research Professional with hands-on experience in clinical trial operations, regulatory submissions, and clinical data management. I specialize in ensuring protocol compliance, GCP adherence, and regulatory excellence for drug and medical device trials across therapeutic areas such as Ophthalmology, Dermatology, Oncology, and Stem Cells. My experience spans site monitoring, CRF/ICF preparation, data validation, and regulatory portal submissions (Sugam, NSWS). I bring a strong foundation in regulatory frameworks like ICH-GCP, MDR 2017, and NDCT 2019, backed by certifications in Medidata Rave EDC and Rapid Study Builder.

専門分野

• ☆ Pharmacy
• ☆ Clinical Pharmacy
• ☆ Drug Development
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Clinical Trials
• ☆ IRB Applications
• ☆ Clinical Trial Design
• ☆ Patient Recruitment
• ☆ Clinical Data Management
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Clinical Trials Data Analysis
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Regulatory Affairs
• ☆ Pharmaceutical Management

サービス

• Writing

Writing Clinical Trial Documentation, Medical Writing, Creative Writing, General Proofreading & Editing

職務経験

Clinical Research Associate II

NCLLP

12月 2023 - 現在

学歴

M Pharmacy

DSTS Mandal’s College of Pharmacy

1月 2020 - 1月 2022

認定資格

• AI tools and Chat GPT workshop

  be10X

  1月 2025 - 現在

• Medidata Rave EDC

  Medidata Academy

  11月 2024 - 現在