**DARSHANA GAIKWAD**
*Maharashtra, India 410208*
*Contact: [Phone Hidden]*
**PROFILE**
Highly motivated and passionate clinical research professional with a master’s degree in pharmacy from the ‘National Institute of Pharmaceutical Education and Research.’ Skilled in clinical trial documentation and ICH GCP guidelines, seeking a challenging role in the clinical operations department to contribute to company goals and foster career growth.
**EXPERIENCE**
**Clinical Research Associate**
*Ardent Clinical Research Services, Pune, Maharashtra (Jan 2025 – Present)*
– Conducted SSV, SIV, IMV, and SCV following organizational SOPs
– Prepared regulatory documents and ensured EC dossier submission
– Managed clinical trial materials, tracking, and logistics
– Maintained study documentation and communication with stakeholders
**Clinical Trial Assistant**
*Insignia Clinical Services Private Limited, Delhi, India (Jan 2024 – Dec 2024)*
– Collected and maintained clinical trial documents in compliance with GCP guidelines
– Assisted in updating and maintaining clinical systems
– Coordinated with sites for study supplies and data flow
**EDUCATION**
– Master of Pharmacy (Pharmacy Practice), National Institute of Pharmaceutical Education and Research Hajipur (7.16 CGPA)
– Bachelor of Pharmacy, University of Mumbai (8.91 CGPA)
**RESEARCH PROJECTS**
– *M Pharm Dissertation*: “Evaluation of vitamin D status and Impact of vitamin D supplement on CD4 cell count, inflammatory and bone Marker in HIV Patients”
– *B Pharm Project*: “Biosynthetic process development of natural product”
**AWARDS**
– Certificate for “Immaculate Punctuality”
– Gold Medal for academic excellence and various other merit certificates
**SKILLS**
Clinical Research Studies, Clinical Trial Documentation, GCP Regulations, GLP, GMP, US FDA, EMA, WHO Guidelines, Lab Skills, Computer Proficiency, Soft Skills
DARSHANA GAIKWAD
Maharashtra, India 410208
Contact: [Phone Hidden]
PROFILE
Highly motivated and passionate clinical research professional with a master’s degree in pharmacy from the ‘National Institute of Pharmaceutical Education and Research.’ Skilled in clinical trial documentation and ICH GCP guidelines, seeking a challenging role in the clinical operations department to contribute to company goals and foster career growth.
EXPERIENCE
Clinical Research Associate
Ardent Clinical Research Services, Pune, Maharashtra (Jan 2025 – Present)
- Conducted SSV, SIV, IMV, and SCV following organizational SOPs
- Prepared regulatory documents and ensured EC dossier submission
- Managed clinical trial materials, tracking, and logistics
- Maintained study documentation and communication with stakeholders
Clinical Trial Assistant
Insignia Clinical Services Private Limited, Delhi, India (Jan 2024 – Dec 2024)
- Collected and maintained clinical trial documents in compliance with GCP guidelines
- Assisted in updating and maintaining clinical systems
- Coordinated with sites for study supplies and data flow
EDUCATION
- Master of Pharmacy (Pharmacy Practice), National Institute of Pharmaceutical Education and Research Hajipur (7.16 CGPA)
- Bachelor of Pharmacy, University of Mumbai (8.91 CGPA)
RESEARCH PROJECTS
- M Pharm Dissertation: “Evaluation of vitamin D status and Impact of vitamin D supplement on CD4 cell count, inflammatory and bone Marker in HIV Patients”
- B Pharm Project: “Biosynthetic process development of natural product”
AWARDS
- Certificate for “Immaculate Punctuality”
- Gold Medal for academic excellence and various other merit certificates
SKILLS
- Clinical Research Studies
- Clinical Trial Documentation
- GCP Regulations
- GLP
- GMP
- US FDA
- EMA
- WHO Guidelines
- Lab Skills
- Computer Proficiency
- Soft Skills
“`
Cover Letter:
Darshana Arun Gaikwad
Deepsagar building room no 903
Plot no 09 taloja phase 2 Navi Mumbai Maharashtra 410208
28/MAY/2025
To the,
Hiring Manager
Panacea Medical Technologies Private Limited
Dear Hiring Manager,
I am writing to express my strong interest in the Clinical Research Associate position at Panacea Medical Technologies Private Limited, as advertised. With a solid foundation in clinical research principles, GCP guidelines, and patient safety protocols, I am confident in my ability to contribute effectively to your clinical trial operations and uphold the highest standards of research compliance and quality.
During my academic and professional journey, I have developed hands-on experience in coordinating and monitoring clinical trials, maintaining essential documents, and ensuring adherence to protocols and regulatory requirements. My attention to detail, coupled with strong organizational skills, has allowed me to effectively manage multiple study sites and foster collaborative relationships with investigators and site staff.
In my previous role at Ardent Clinical Research Services Private Limited, I was responsible for site initiation, interim monitoring, and close-out visits. I successfully ensured protocol compliance and accurate data collection, while proactively addressing site issues and discrepancies. My understanding of ICH-GCP and FDA regulations, as well as my proficiency with electronic data capture systems, has consistently contributed to audit-ready documentation and smooth trial progress.
What draws me to Panacea Medical Technologies Private Limited, is your reputation for innovation and ethical research practices. I am particularly impressed by your recent work and I am excited by the opportunity to support your mission in bringing high-quality, evidence-based treatments to patients.
I would welcome the opportunity to bring my enthusiasm and dedication to your team. Thank you for considering my application. I have attached my resume for your review and would be pleased to discuss my qualifications further in an interview.
Sincerely,
Darshana Arun Gaikwad
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