Shivani Haribhau Dangle
Navi Mumbai
Summary
Experienced Clinical Research Associate dedicated to maintaining study protocols, standard operating procedures, and good clinical practices. Recognized for effective problem-solving abilities and meticulous attention to detail. Seeking an opportunity to utilize skills and contribute meaningfully to company growth.
Overview
2
2
years of professional experience
1
1
Certification
Work History
Executive-Clinical Research Associate
Vivotech Research Lab Pvt Ltd
02.2023 - Current
- Monitored and managed 07 clinical trials, ensuring compliance with GCP and FDA regulations
- Led site initiation visits and conducted 25+ monitoring visits across multiple locations, maintaining 100% adherence to study protocols
- Increased subject enrollment by 20% through collaboration with site staff and implementation of new recruitment strategies
- Monitored and verified 200 patient case report forms (CRFs), achieving a 98% data accuracy rate during interim analysis
- Led data verification and query resolution processes, achieving a 98% data accuracy rate and ensuring clean data submission for database lock in e-CRF
Education
Bachelor of Pharmacy -
Gahlot Institute of Pharmacy
05-2022
Skills
- Strong organizational skills and time-management skills
- Verbal and written communications skills
- Ability to work independently and as part of a team
- Detail-oriented and able to handle multiple tasks simultaneously
- Attention to detail
Hard Skills
- Clinical Trial Management Systems (CTMS)-Proficient in using CTMS platforms for planning, tracking, and managing clinical trials, ensuring timely study updates and compliance.
- Electronic Trial Master File (eTMF)-Managed clinical trial documentation using eTMF systems, ensuring proper storage, organization, and retrieval of essential study documents.
- User Acceptance Testing (UAT)-Conducted UAT for clinical systems to ensure they meet operational requirements, identifying bugs and optimizing workflow processes.
- e-CRF (Electronic Case Report Form) Query Management – Generated and resolved queries in e-CRF systems to ensure data accuracy, completeness, and compliance with study protocols
- Ms Office
Hobbies and Interests
- Tutoring
- Hiking
- Internet Surfing
Certification
- Good Clinical Practice by NIDA
- Design and Interpretation of Clinical Trials by Johns Hopkins University from Coursera
- Excel Basics for Data Analysis by IBM from Coursera
Languages
English
Hindi
Marathi
Personal Information
- Date of Birth: 11/06/00
- Gender: Female
- Nationality: India
- Marital Status: Unmarried
Disclaimer
I hereby declare that the above information is correct and true to the best of my knowledge.
Timeline
Executive-Clinical Research Associate
Vivotech Research Lab Pvt Ltd
02.2023 - Current
- Good Clinical Practice by NIDA
- Design and Interpretation of Clinical Trials by Johns Hopkins University from Coursera
- Excel Basics for Data Analysis by IBM from Coursera
Bachelor of Pharmacy -
Gahlot Institute of Pharmacy
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