Experience

Coordinated all aspects of clinical trials in compliance with IRB protocols, GCP, and regulatory guidelines. Conducted informed consent, screened and enrolled participants, and supported subject safety throughout the study. Managed study visits, follow-ups, and adverse event reporting. Maintained source documents and regulatory files, submitted IRB/FDA documents, and registered studies on ClinicalTrials.gov. Completed case report forms, responded to queries, and facilitated monitoring visits and study closeouts. Processed lab specimens, managed investigational product accountability, and resolved billing issues. Drafted consent forms, edited IRB protocols, trained junior staff, and supported multi-site study operations and communications.

During my tenure as a Medical Imaging Data Analyst, I spearheaded the streamlined analysis and processing of over 20 medical imaging data sets daily for clinical trials, meticulously ensuring adherence to study protocols. This initiative significantly bolstered efficiency and accuracy within the data handling processes, thereby amplifying the efficacy of our clinical research endeavors. Additionally, I adeptly resolved more than 150 queries with investigator sites and academic centers, navigating complex regulatory landscapes with precision to maintain exemplary data quality and uphold compliance standards. Leveraging my expertise, I also conducted comprehensive training sessions and provided mentorship to 30 internal personnel, empowering them with best practices for handling medical imaging data. This dedication resulted in a notable enhancement of the team's knowledge and skills, further fortifying our capacity to deliver impactful contributions to the field of clinical research.

In my role as a Clinical Research Coordinator, I have demonstrated proficiency in a wide array of essential tasks vital to the success of clinical trials. From meticulously maintaining investigator site files and ensuring accountability for investigational products to overseeing patient recruitment, counseling, and follow-up procedures, I have consistently upheld the highest standards of quality and efficiency. My adherence to ICH-GCP guidelines and protocols, coupled with my dedication to accurate record-keeping and meticulous documentation of study-related activities, has been instrumental in ensuring the efficacy and integrity of all clinical trial processes. Furthermore, my expertise extends to executing streamlined workflows for study activities, including the completion of CRF and e-CRF forms, preparing monitoring site visit reports, and liaising effectively with principal investigators, study sponsors, and ethics committees to facilitate smooth study operations.

During my tenure leading a 12-month internship in the Antibacterial Stewardship Program, I showcased expertise in clinical pharmacy  to enhancing patient care. Playing a pivotal role in monitoring Surgical Antibiotic Prophylaxis (CT-OT), I ensured optimal patient outcomes by demonstrating a keen understanding of infection prevention protocols. Through thorough reviews of patient case files, I contributed to the development of precise treatment charts aligned with best practices in antibiotic management. Collaborating closely with medical professionals during patient rounds, I actively regulated high-end antibiotics like Meropenem, Linezolid, and teicoplanin, showcasing proficiency in medication management. Applying in-depth pharmaceutical knowledge, I assisted doctors in making informed decisions, promoting responsible prescribing practices and emphasizing a proactive approach to antibiotic usage. My versatility in navigating the complexities of high-impact antibiotics contributed to treatment plan optimization and minimized the risk of antibiotic resistance.