As a successful clinical research and patient care professional with over a decade of experience, I have experience in Asian and American research industries and have a strong track record of supporting program needs and managing projects with little oversight. I excel in reviewing and assessing processes and implementing continuous improvement initiatives to streamline office operations. I have a strong publication record, having authored several journal articles. I believe in continued learning for professional development and have developed proficiency in pharmacovigilance, research regulatory operations, medical writing, budget management, and project management.
- I worked directly with principal investigators and directors of research to oversee post-award-related operations for more than 50 research studies.
- Responsible for budget tracking, financial projections, and reporting activities for multiple research grants and contracts.
- Served as the liaison between business administration and research investigators, ensuring smooth communication and collaboration between both teams.
- Prepared budget plans and justifications for new research projects, contracts, and sub-awards.
- Tracked the effort distributions of staff for teams in the Department of Family and Community Medicine (FCM).
- Led departmental research meetings and served as an international guest speaker for leadership training.
- Led teams for manuscript writing and statistical research analysis, ensuring timely and accurate completion of projects.
- Supervised financial team for more than ten studies, ensuring adherence to budgetary constraints and financial regulations.
- Led e-IRB submission team for primary and ancillary studies of the same project, maintaining accurate records and timely submission of all necessary documentation.
- Utilized strategic and organizational skills to keep up with the timelines of all the studies, resulting in the timely completion of all financial tasks.
- Acted as a member of the interview committee for the project, providing valuable input on selecting candidates for various roles.
- Initiated a new virtual debit card payment method for a million-dollar grant project at the University, simplifying the payment process and reducing errors.
- Contributed to an original research paper and was part of a few publications as an author and contributor.
- Created manuals, SOPs, and FAQ sheets on finance-related processes for the study to assist the team, ensuring consistency and accuracy in financial tasks.
- I managed budget tracking of the $ 22 million grant and provided projections, identifying and resolving potential issues promptly.
- Acting Site Lead and managed finances for various research sites.
- Performed daily clinical research operations and prepared necessary documents.
- Trained and managed team members to increase the number of research participant enrollments.
- Evaluated and supervised new staff for recruitment, engagement, enrollment, and documentation process.
- Independently worked in a lab for handling samples, processing, finalizing, and shipment.
- Maintained, tracked, and analyzed outpatient clinics and inpatient statistics.
- Conducted coaching and team sessions on biostatistics in research.
- Provided guidance to new coordinators for phlebotomy and understanding lab responsibilities.
- Monitored the end-to-end process for various phases of multicentric clinical trials on multiple indications.
- Provided project-specific administrative support and built relationships with investigators and site IRB staff for conducting trials.
- Responsible for regularly meeting tight deadlines by developing long and short-term goals for my team.
- Performed scenario planning by identifying site issues and initiated correction plans based on monitoring reports.
- Trained site staff for the protocols and the trial-related reporting of serious adverse events, deviations, and violations.
- Assisted in finalizing budget negotiation, including insurance agreements for trials.
- Maintained Site Master, Trial Master Files, and all related logs at sites and the company level.
- Designed and edited documentation that included Investigational New Drug (IND-FDA/DCGI submissions), Statistical Analysis Plan (SAP), Case Study Report (CSR) documentation, electronic data capture tools (e-CRF), draft contracts for clinical sites, and publication articles.
- Worked as clinical and research teaching assistant for undergraduate dental students.
- Planned, organized, and managed several health check-ups and dental treatment camps in local areas, providing care for underserved populations.
- Presented dental seminars and research papers, demonstrating strong communication skills and subject matter expertise.
- Critically evaluated various scientific articles, demonstrating analytical and critical thinking skills.
- Conducted end-to-end dental research, including descriptive and analytical studies, and published original research studies in indexed peer-reviewed journals.
- Worked on research grant proposals and collaborated with pharmaceutical organizations in India and Japan for thesis projects, demonstrating strong project management and collaboration skills.
- Developed, maintained, and implemented oral care strategies for clinical programs, showing a dedication to improving patient care outcomes.
- Worked on a new molecule for hypovolemic shock treatment from Phase 0 to Phase I.
- Managed the documentation and IND submission for approval of non-clinical research studies.
- Developed and reviewed Protocol, ICD, CRF, IB, SOPs/working and scheduling instructions
- Published important outcomes in peer-reviewed journals and prepared draft clinical study Reports for Phase III to IV.
- Performed maxillofacial surgeries and all basics to advanced dental-related procedures
- Collaborated with all specialized dental surgeons and was trained to manage and organize dental clinical skills.