Sakshi Kasana

• Supervised and managed a team of 16 members in a randomized clinical trial (site: Department of obstetrics and gynecology, LHMC)
• Coordinated participant recruitment for the study, ensuring compliance with regulatory guidelines.
• Managed study documentation and maintained accurate records in electronic data capture systems.
• Assisted in developing study protocols and informed consent forms to enhance participant understanding.
• Prepared weekly and monthly study progress reports
• Trained new staff on standard operating procedures and best practices in clinical trial management.

• Enrollment and Consent Process:
  Conducted detailed discussions with parents/guardians of neonates to explain the study objectives and procedures.
  Obtained written informed consent in accordance with ethical guidelines and GCP standards.
• Clinical Training and Application:
  Successfully completed training in IMNCI (Integrated Management of Neonatal and Childhood Illnesses) and GCP (Good Clinical Practice).
• Diagnosis and Referral Management:
  Diagnosed Possible Serious Bacterial Infections (PSBI) in neonates referred by field investigators to the study hospital. Provided timely clinical evaluations and ensured appropriate case management.
• Investigational Product (IP) Management:
  Maintained the inventory and accountability of investigational products (IP) at the study site.
  Ensured proper storage, dispensing, and documentation as per protocol and regulatory requirements.
• Site Documentation and Compliance:
  Maintained the Investigator Site File (ISF), ensuring all essential documents (e.g., protocols, SOPs, logs) were up-to-date and audit-ready.
• Safety Reporting:
  Identified, documented, and reported Adverse Events (AE) and Serious Adverse Events (SAE) to the Principal Investigator (PI).
  Prepared detailed case summaries for each AE/SAE as part of the pharmacovigilance process.

• Worked at Lady Hardinge Medical College as “Research Officer” under the ICMR project “Implications of antibiotic use to the preterm infant respiratory Microbiome and Resistome Development” for 7 months (July 2019 - January 2020)
• Enrollment and Consent Process

Conducted detailed discussions with parents/guardians of neonates to explain the study objectives and procedures.
Obtained written informed consent in accordance with ethical guidelines and GCP standards.

• Sample Collection Coordination:

Facilitated sample collection from neonates as per study protocol. Ensured proper labeling, storage, and transportation of samples while maintaining the cold chain to preserve sample integrity.

• Collected data of immunization record in children admitted in department of pediatrics (Site: LHMC)

• Contributed as Intern in Roko Cancer Charitable Trust (April-June) for project on Breast Cancer Awareness driven by Department of Science and Technology (DST) and Punjab State Council for Science & Technology
• Organized and conducted Health check-up camps in Delhi-NCR as a part of internship at Roko Cancer Charitable Trust.
• Assisted in organizing community events to raise awareness for cancer prevention and research initiatives.