Clinical Research Coordinator

ASTHA TAMBE

Pune, Maharashtra +91-862******* ************@*****.*** LinkedIn:

https://www.linkedin.com/in/astha-tambe-73275118b

PROFESSIONAL SUMMARY

MSc Clinical Research graduate with practical experience in clinical trial coordination, EDC (Viedoc 4), and regulatory document management. Proficient in interpreting trial protocols, NDCTR, and USFDA guidelines. Detail-oriented team player with a strong foundation in site-level operations, eager to grow into project and client-facing roles in clinical research. INTERNSHIP EXPERIENCE

Ruby Hall Clinic, Pune Jan 2025 – May 2025

• Assisted in patient visit coordination by interpreting protocol-defined visit windows.

• Worked with CRFs in EDC system (Viedoc 4) ensuring accurate data entry and resolving discrepancies.

• Observed Site Initiation and Monitoring Visits, gaining exposure to site activation and sponsor expectations.

• Updated Investigator Site Files (ISF), contributing to timely audit and inspection readiness.

• Contributed to Ethics Committee (EC) dossier preparation, supporting smooth approval processes. Kolhapur Cancer Centre, Kolhapur May 2024 – July 2024

• Worked with HMIS software and contributed to patient pre- screening for oncology trials.

• Supported consent handling, and visit coordination, improving subject enrollment and visit compliance.

• Assisted in reviewing the current SOP, implementing required modifications, and drafting the new version for internal use.

Piramal Pharma Solutions, Mahad June 2022 – July 2022

• Observed end-to-end GMP operations in manufacturing departments, QA, QC gaining foundational exposure to quality-driven R&D environments. ACADEMIC PROJECTS

Balancing Ethics and Efficiency: A Comparative Study of Clinical Trial Guidelines in India and the USA [Jan 2025 – May 2025]

• Compared NDCTR and US FDA guidelines; identified regulatory gaps and proposed harmonization strategies to improve both ethical oversight and operational efficiency in trial conduct.

Knowledge, Perspective, Attitude of Regional Population Towards ADR Reporting of Type II Diabetes Mellitus. [Jan 2023 – June 2023]

• Designed and executed a survey to assess ADR awareness, identified knowledge gaps, and proposed strategies to improve pharmacovigilance compliance. Extraction and Identification of Alkaloid Vasicine from Adhatoda vasica by using Thin Layer Chromatography. [Sept 2022- Dec 2022]

• Successfully extracted and identified Vasicine using Thin Layer Chromatography, demonstrating a reproducible method for herbal compound analysis and contributing to quality assurance in traditional medicine.

EDUCATION

MSc. Clinical Research Ajeenkya D. Y. Patil University, Pune July 2023 – July 2025 CGPA- 9.71 B. Pharm Sanjay Ghodawat University, Kolhapur June 2019 – June 2023 CGPA- 8.38 SKILLS

Clinical & Technical: Patient Screening & Recruitment, EDC data entry, Patient visit coordination, Ethics Committee dossier preparation, ISF management, MS Office Suite, HMIS Software Operation Regulatory Knowledge: ICH-GCP Guidelines, NDCTR 2019, US FDA 21 CFR Guidelines, Good Documentation Practice, Risk Based Quality Management Approaches (RBQM) Soft Skills: Detail-oriented, Communication, Time management, Problem Solving, Adaptability CERTIFICATION AND TRAINING

• GCP NIDA Certification

• IATA Certification

• National Cancer Grid BIRAC-CTN Clinical Research Training PUBLICATIONS

• Astha Tambe, “Digital Transformation of Clinical Research: Facilitating Decentralized Clinical Trials in India.” International Journal of Clinical Trials, Accepted for Publication, 2025.

• Astha Tambe. et al., (2023). “Extraction and Identification of Vasicine from Adhatoda vasica by using TLC Method”, European Journal of Biomedical and Pharmaceutical Sciences, 10 (10), 267-268.

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