Shweta Thakur
Mumbai
Summary
Knowledgeable Clinical Research Associate with 2 years of experience in documenting and assisting in clinical trials research. Clear, concise and effective written communication abilities. Good knowledge of FDA and GCP principles and regulations. Committed to providing support to the project team and executing responsibilities as instructed.
Overview
2
2
years of professional experience
Work History
Clinical Research Associate
Macleods Pharmaceuticals Ltd.
Mumbai
12.2021 - Current
- Performed clinical research activities including protocol development, subject recruitment and data collection.
- Reviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.
- Conducted site initiation visits and monitored ongoing studies at investigator sites.
- Assessed incoming source documentation for accuracy and completeness against case report forms.
- Prepared reports summarizing study progress and results for senior management review.
- Tracked enrollment status across multiple sites to ensure target goals were met in a timely manner.
- Adhered to good clinical practices, operating procedures and regulatory requirements.
- Supported investigator selection and qualification process by offering professional input.
- Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
Education
Master of Science - Clinical Research
Institute of Clinical Research India
Mumbai05.2021
Skills
- Status Reporting
- Site Management
- Monitoring Visits
- Project Monitoring
Languages
Maithili
First Language
English
Intermediate (B1)
B1
Hindi
Intermediate (B1)
B1
Marathi
Elementary (A2)
A2
Affiliations
- Travelling
- Dancing
- Sketching
Timeline
Clinical Research Associate
Macleods Pharmaceuticals Ltd.
12.2021 - Current
Master of Science - Clinical Research
Institute of Clinical Research India
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