Venkata Sai Rohit Vuppalapati

Roles and Responsibilities:

Study Documentation and Protocol Development

• Assisted in the development and review of study-related documentation including protocols, case report forms, and informed consent forms.
• Selection of potential investigators and investigational sites, preparation of Ethics committee submissions, notifications to regulatory authorities, translation of study-related documents, and organization of meetings.

Site Management and Monitoring

• Identified and selected investigators responsible for conducting trials at trial sites.
• Set up trial sites, ensuring each center had the trial materials, including the investigational medicinal product.
• Coordinated the procurement and distribution of essential study materials such as lab kits, investigational medicinal products, and source documents to ensure efficient operation and execution of clinical trials at various sites
• Conducted site initiation, monitoring, and close-out visits for multiple clinical trials in adherence to protocol requirements and regulatory standards.
• Coordinated with investigators, study coordinators, and sponsors to ensure timely and accurate data collection and entry.
• Participated in internal and external audits to ensure compliance with regulatory guidelines and Good Clinical Practice (GCP).
• Managed Trial Master File (TMF), maintaining meticulous records and documentation to facilitate audits and inspections.

Training and Communication

• Trained study staff in standard operating procedures for clinical trials as per applicable regulatory requirements.
• Prepared presentations and agendas for meetings, ensuring clear communication and alignment among stakeholders.
• Planned and executed successful Investigator Meetings for Phase II trials for up to 200 attendees, including Principal Investigators and study coordinators.

Data Management and Safety Reporting

• Performed data verification and resolved queries to ensure data integrity and accuracy throughout the study.
• Verification and review of adverse events, serious adverse events, concomitant medications together with corresponding illnesses to confirm accurate data reporting in accordance with protocol.

Global Study Participation

• Actively participated in global clinical studies by serving as a centralized monitor. Responsibilities included thorough review and assessment of Site Qualification Reports, Site Initiation Reports, and Site Monitoring Reports. Ensured adherence to protocol and regulatory requirements across all monitored sites.

Medical Publications and Scientific Writing

• Developed high-quality scientific content for a variety of medical publications, including research articles, review papers, and educational materials.

Financial Management

• Oversaw budgeting and financial forecasting processes to ensure timely invoice generation and processing for the clinical trial sites.