Rakshitha M

About Rakshitha M

As a PharmD intern at MVJ Medical College and Research Hospital (MVJMC & RH), and currently serving as a Clinical Trial Assistant at Samahitha Research Solutions, I apply my expertise in data analysis and clinical trials to support the advancement of pharmaceutical research. I hold a Doctor of Pharmacy degree from Krupanidhi College of Pharmacy, where I built a strong foundation in pharmacology, toxicology, and pharmaceutical chemistry.My role at Samahitha Research Solutions involves assisting in the planning, coordination, and monitoring of clinical trials. I support the preparation of trial documentation, manage clinical trial data, ensure compliance with ICH-GCP guidelines, and collaborate with cross-functional teams to maintain high standards in research integrity and patient safety.Additionally, I am certified in Clinical Data Management and ICH GCP guidelines, enabling me to handle complex datasets with precision and ensure strict adherence to international regulatory standards. My goal is to leverage my growing experience in clinical research to contribute to the development of safe, effective, and innovative pharmaceutical products.

Experience

1. Clinical Trial Assistant

   Samahitha Research Solutions

   May 2025 — Present · Bengaluru, IN

   Coordinated with site teams to ensure effective patient recruitment and timely execution of study activities.• Assisted in on-site monitoring, including review of ICFs, source documents, CRFs/eCRFs, regulatory files, IP accountability, and site logs.• Managed site selection, qualification activities, and collection of essential regulatory documents.• Supported study startup activities: site initiation, interim monitoring, and closeout visits.• Assisted Project Managers and CRAs in planning and executing pre-study activities; maintained feasibility and study trackers.• Maintained Trial Master File (TMF) and Investigator Site File (ISF) documentation in compliance with ICH-GCP and SOPs.• Prepared and reviewed Ethics Committee submission dossiers; tracked regulatory submissions and approvals.• Monitored clinical sites for protocol compliance and quality management requirements.• Managed lab costing, study budgets, and Clinical Trial Agreements (CTA); supported IP management.• Prepared study trackers, monitoring reports, and minutes of meetings (MoM).• Ensured timely resolution of data queries and coordinated corrective actions.• Prepared source documents and compiled raw study data.• Experienced in EDC platforms (Medilake).• Successfully handled and coordinated CRO and SMO project

Education

• Christ Academy Institute for Advanced Studies

  PUC

  2016 — 2018

• Saraswathi vidya mandira

  SSLC

  2006 — 2016

• Krupanidhi College of Pharmacy

  Doctor of Pharmacy - PharmD

  2018 — 2024