Vaishnavi Yeshirao

Clinical Research Associate | Mumbai

Professional Summary

Detail-oriented Clinical Research Professional with 1.5 years of experience supporting end-to-end clinical trial execution under ICMR. Skilled in eCRF development, on-site and remote monitoring, IRB submissions, and maintaining data integrity. Knowledgeable in ICH-GCP guidelines, regulatory frameworks, and ethical standards. Seeking to leverage experience and technical skills in a Clinical Research Associate (CRA) role to ensure protocol compliance, subject safety, and high-quality data collection.

Technical Skills

• Clinical Trial Monitoring (On-site & Remote)
• Patient Safety & Data Integrity Monitoring
• eCRFs & Data Management Systems (Castor EDC, Veeva Vault)
• ICH-GCP, 21 CFR Part 11, Regulatory Compliance
• Ethical Submissions & IRB Coordination
• Data Validation & Cleaning
• Clinical Trial Lifecycle Management

Soft Skills

• Attention to Detail
• Communication
• Team Collaboration
• Critical Thinking
• Time Management

Certifications

• Principles and Practice of Clinical Research (NIH)
• Good Clinical Practice (NIDA)
• Clinical Data Management (Biotecnika)
• Regulatory Affairs
• Mini-Course EU MDR

Professional Experience

Project Technical Support III (ICMR Ad-hoc)

LTMMC, Mumbai | Mar 2023 – Sep 2024

• Conducted remote and on-site clinical monitoring activities in compliance with study protocols and GCP standards.
• Oversaw 100+ patient enrollments and ensured >90% follow-up adherence.
• Collected, cleaned, and validated clinical data using Castor EDC and Veeva Vault.
• Contributed to ethical and regulatory submissions and liaised with institutional ethics committees and sponsors.
• Ensured timely reporting and documentation of trial activities, maintaining audit readiness.
• Supported preparation of interim analysis and clinical reports.

Key Achievements

• Independently managed trial lifecycle ensuring protocol adherence.
• Played a key role in maintaining patient safety and high data quality standards.

Education

Master of Science in Microbiology

HBSU, Mumbai | 2020 – 2022

Bachelor of Science in Microbiology

University of Mumbai | 2017 – 2020

Languages

English | Hindi | Marathi

Skills

Clinical Trial Monitoring, Data Integrity Monitoring, eCRFs, ICH-GCP, Regulatory Compliance, Ethical Submissions, Data Cleaning, Clinical Reports, Attention to Detail, Communication, Team Collaboration, Critical Thinking, Time Management

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Cover Letter:

Dear Hiring Manager,

I am writing to express my strong interest in the Clinical Research Associate (CRA) position at Panacea Medical Technologies . With 1.5 years of hands-on experience in clinical data coordination under the ICMR, I am confident in my ability to contribute effectively to your clinical trial operations and uphold the highest standards of research quality and compliance.

In my previous role, I led the full lifecycle of clinical studies, from ethical submissions and eCRF development to monitoring data integrity and regulatory compliance. I successfully managed over 100 patient enrollments, maintaining a 90%+ follow-up rate and collaborating closely with site staff and sponsors to ensure accurate and timely data collection. My familiarity with ICH-GCP guidelines, data privacy standards, and tools like Castor EDC and Veeva Vault equip me to monitor trials rigorously and support your team’s success.

I am particularly drawn to your organization’s commitment to advancing high-quality clinical research. I bring not only technical competence and attention to detail but also strong interpersonal skills that enable smooth collaboration across cross-functional teams and investigative sites.

I would welcome the opportunity to further discuss how my background aligns with your goals. Thank you for considering my application. I look forward to the possibility of contributing to your team’s impactful work.

Warm regards,
Vaishnavi Yeshirao