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Saba P. — Mid-Level Clinical Research Coordinator from India

Saba P.

Mid-Level Clinical Research Coordinator

India Less than 1 year
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EnglishHindi
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About

Saba P. is a Clinical Research Coordinator (CRC) with over two years of experience, specializing in respiratory and cardiac Phase III clinical trials. She has been integral to the Department of Tuberculosis and Respiratory Medicine at J.N. Medical College & Hospital (JNMCH), Aligarh Muslim University (AMU), where she coordinates daily trial activities, ensuring protocol compliance with ICH-GCP standards. Her role involves conducting patient screening and informed consent processes, managing study participants, and maintaining rigorous oversight of data integrity. Saba's expertise includes precise SAE reporting, maintaining the Investigator Site File (ISF), and supporting sponsor audits with no findings reported. She holds an M.Sc in Microbiology from Dr. B.R. Ambedkar University, further underpinning her detailed approach to regulatory documentation. Her training in diagnostic microbiology complements her real-world experience in managing complex clinical trials, making her a skilled asset in clinical research management.

Experience

  • Clinical Research Coordinator (CRC)

    Department of Tuberculosis and Respiratory Medicine, J.N. Medical College & Hospital (JNMCH), Aligarh Muslim University (AMU) · 2023 — Present
    Coordinated daily activities of clinical trials at the site level while ensuring compliance with ICH-GCP and protocol guidelines. Engaged in patient screening, informed consent, enrollment, and follow-up visits. Managed study participants, maintained schedules, and adhered to protocol requirements. Executed Serious Adverse Event (SAE) reporting with timely submissions to the sponsor and IEC. Managed the Investigator Site File (ISF), source documents, and regulatory records. Conducted accurate data entry into eCRF/EDC systems and addressed queries from monitors. Assisted during monitoring visits, audits, and regulatory inspections, supporting the Investigator in protocol deviations and documentation. Focused on patient safety, data integrity, and compliance throughout the study process.
  • Trainee – Bacteriology Laboratory

    Department of Microbiology, JNMCH, AMU, Aligarh · 2023 — 2023
    Executed culture techniques for pus and urine samples, along with antimicrobial susceptibility testing. Conducted biochemical tests such as catalase and oxidase while adhering to aseptic methods and laboratory safety protocols.
  • Intern

    Department of Microbiology, JNMCH, AMU, Aligarh · 2023 — 2023
    Focused on diagnostic microbiology and laboratory procedures including the handling and processing of clinical samples, as well as antibiotic susceptibility testing and reporting.

Skills & Expertise

Education

  • Master of Science in Microbiology
    Dr. B.R. Ambedkar University, Agra · — — 2023
  • Bachelor of Science in Zoology, Botany, Chemistry
    Dr. B.R. Ambedkar University, Agra · — — 2021
  • Senior Secondary (XII)
    CBSE, New Delhi · — — 2018
  • Secondary (X)
    CBSE, New Delhi · — — 2016

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