Shweta Kumavat

Clinical Research professional with hands-on experience in Phase III clinical trials, oncology studies, and hospital-based research coordination. Skilled in patient screening, informed consent, SAE reporting, CRF documentation, and clinical trial systems (EDC, TMF). Proven ability to manage study documentation, coordinate with investigators, and ensure compliance with ICH-GCP and regulatory standards.

Seeking to contribute to high-quality clinical trials in a growth-oriented organisation with strong focus on data accuracy, audit readiness, timeline management, and cross-functional collaboration.

Pharmacist at King Edward Memorial Hospital (KEM Hospital) (2025-09 – Present)

• Dispense medications, ensuring accuracy, patients safety and regulatory compliance.
• Counsel patients on dosage, adherence and drug safety.
• Maintain inventory, storage conditions and documentation records.
• Collaborate with healthcare teams to support safe medication practices.

Clinical Research Trainee (CTA) at Alkem Laboratories Pvt. Ltd. (2021-10 – 2022-05)

• Supported Phase III, randomised clinical trial (Endocrinology – MSP1 study).
• Maintained Trial Master File (e-TMF) ensuring audit readiness.
• Worked on EDC & CTMS systems for data entry and tracking.
• Prepared study related essential documents, reports and CTA agreements, invoices.
• Track the study records and prepared trackers, Minutes of meeting (MOM).
• Coordinated with teams for study Updates and documentation management.

Clinical Research Coordinator (CRC) at Tata Memorial Hospital (2021-09 – 2021-10)

• Screened patients and managed informed consent process.
• Performed CRF data entry and maintained clinical databases.
• Reported Serious Adverse Events (SAEs) within regulatory timelines.
• Coordinated patient visits, dosing, and safety follow-ups.
• Ensured protocol compliance and patient safety.

PostGraduation in Advanced Clinical Research in Clinical Research – Institute of Clinical Research (ICRI), Mumbai (2020 – 2021)

Bachelor of Pharmacy (B. Pharmacy) in Pharmacy – MET Institute Of Pharmacy, Mumbai (2015 – 2019)