Profile Details

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USD 10 /hr

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Hire Vrushali P.

India

USD 10 /hr

Freelance Clinical Research and Regulatory Affairs Professional Medical Writing, Documentation

Profile Summary

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.

Subject Matter Expertise

• ☆ 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

Services

• Writing

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

Work Experience

Clinical Research Associate II

NCLLP

December 2023 - Present

Education

M Pharmacy

DSTS Mandal’s College of Pharmacy

January 2020 - January 2022

Certifications

• AI tools and Chat GPT workshop

  be10X

  January 2025 - Present

• Medidata Rave EDC

  Medidata Academy

  November 2024 - Present