Alekhya Lakshmi

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.

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

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)