Dynamic Clinical Research Coordinator at UTMB Health with expertise in regulatory compliance and patient recruitment. Proven ability to manage clinical trials effectively while demonstrating outstanding leadership and meticulous attention to detail. Skilled in specimen processing and budget management, ensuring ethical study execution and participant satisfaction.
Overseeing and managing clinical trials and research studies to ensure they are conducted in compliance with regulatory guidelines and protocols. Working with PIs, sponsors, and study participants to ensure smooth and ethical study execution. Creating recruitment strategies and retention plans for all age groups and demographics. Recruit, screen, and enroll study participants according to study protocols. Obtain and document informed consent from participants. Schedule and conduct study visits, follow-ups, and data collection. Specimen collection and processing. PBMC experience, processing patient samples and quarterly submission for Duke IVQAC. Maintain accurate, up-to-date, and confidential records of all participant data. Ensure compliance with GCP, IRB, FDA, and institutional regulations. Assists in budget preparation and monitors study-related expenses. Handle preparation and submission of regulatory documents, such as IRB applications, amendments, and continuing reviews. Manage the inventory of IP when applicable, and study supplies. Upkeep of schedules, including but not limited to participant visits, monitoring visits, SIVs, laboratory inspections, timekeeping, etc. Coordinating and managing events. Web design, keeping the website and social media up to date.