Pauline Varna R

• Developed strong relationships with clinical teams, ensuring seamless communication and collaboration for study execution.
• Supported study teams in the development and implementation of risk mitigation strategies, ensuring alignment with organizational goals and objectives.
• Maintained up-to-date knowledge on industry best practices through participation in conferences, workshops, and training sessions related to central monitoring methodologies.
• Facilitated effective decision-making through the provision of detailed analysis reports on site performance metrics to relevant stakeholders.
• Contributed to the development of Central Monitoring Plans, aligning study objectives with effective monitoring techniques.

Site Feasibility

Preparation and Maintenance of Trial Master File.

Preparation and organization of Investigator Meetings, Training and Seminars.

Ethics Committee Submissions and follow-ups.

Maintaining knowledge of ICH GCP and country specific guidelines.

Ensured trials are conducted in compliance with regulatory standards set

SAE Reporting.

Training and mentoring new Research Associates

• Lectured and handled practical classes for 2nd year MBBS students on the Various branches of Medical Microbiology namely
• Systematic Bacteriology, Immunology, Virology, Parasitology.
• Conducted educational assessments and identified areas that needed improvement.
• Developed teaching materials in the form of interactive presentations.
• Maintained records of student assessments, tutoring activities and results.
• Led tutoring workshops for groups of students with related tutoring needs.