Medical Writer/ Research Assistant
Current• Worked in a group of physicians under the leadership of Dr. Urvish Patel. I attended research meetings and discussions on zoom video call remotely • Collectively engaged in literature review, data collection, writing research protocols, analyzed collected data, wrote methodology, results, charted tables and completed the discussion part of the research paper • Completed and presented projects at prestigious national conferences and submitted projects in AHA, SGIM, ACC, ESC, Cureus • Project management and writing support using Microsoft Project and Smartsheet and assign staff and resources to ensure monitoring for ongoing projects and initiatives • Assess the need for external resource procurement • Peoples’ manager to new hires training, mentoring and development, retention strategies and performance improvement • Conduct and oversee onboarding and training of CRAs based on their area of expertise • Lead author for CERs, PMCF Plans and PMCF Reports • Lead project manager for Quality Management System development and operations • Working knowledge of ICH-GCP, ISO 13845, EU MDR 2017/745, 21 CFR titles, MDCG 2020-2 rev.1, MDCG 2021-24, MDCG 2022-5 • Collaborate with subject matter experts and assist in clinical site activation • Provide direction in the strategic assessment of relevant technologies and procedures, as applicable • Implement new directives, systems, and procedures • Strong working knowledge of Good Clinical Practices (GCP), FDA, ISO regulations, and current industry standards