Alekhya Lakshmi
M.Sc. Clinical Research graduate with hands-on experience in hospital-based clinical trial operations
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About
M.Sc. Clinical Research graduate with hands-on experience in hospital-based clinical trial operations. Trained in GCP, EDC/CRF documentation, informed consent, and ethics committee processes. Seeking an entry-level Clinical Research Coordinator / Clinical Research Associate role.
Experience
Clinical Research Trainee - Malla Reddy Clinical Research Unit - Hyderabad
(2024-04 - 2024-05)
Completed a two-month clinical research training program, gaining practical exposure to clinical trial processes and site operations. Developed strong skills in clinical documentation, patient interaction, data accuracy, and research site management, with a solid understanding of Good Clinical Practice (GCP) and ethical standards in clinical research.
- Assisted in Case Report Form (CRF) completion
- Trial Master File (TMF) documentation
- Informed consent procedures
- Patient screening and study coordination
- Ensured compliance with ICH-GCP guidelines and regulatory requirements
Clinical Research Intern (CRC) - KIMS Hospital - Secunderabad
(2025-03 - 2025-06)
Gained practical exposure to clinical trial operations and site management with focus on patient interaction, data accuracy, and regulatory compliance.
- Assisted in patient screening and recruitment according to protocol-defined inclusion and exclusion criteria
- Supported the informed consent process under supervision
- Contributed to electronic data capture (EDC) and case report form (CRF) data entry while maintaining accuracy and regulatory compliance
- Coordinated patient follow-up visits and ensured proper documentation throughout the study
- Gained practical exposure to Institutional Ethics Committee (IEC) procedures
- Serious adverse event (SAE) and adverse event (AE) reporting
- Maintenance of regulatory binders
Education
M.Sc. - Clinical Research & Experimental Medicine - Malla Reddy University (2023 - 2025)
B.Sc. - Botany, Zoology, Chemistry - Kakatiya University (2020 - 2023)
Intermediate - BIPC - Srivani Junior College for Girls (2018 - 2020)
SSC - ZPHS Kandukuru (2017 - 2018)
