Orielle Caudle

Master's

Public Health

Clinical Research Coordinator

- AL - Thermo Fisher Scientific - Work as a CRC on the RSV vaccination clinical trial team. Serving as the lead coordinator maintaining the site's largest study. In addition to leading studies with other indications that include obesity, hypertension, and high cholesterol to name a few - Ensured quality assurance and compliance for all studies as well as maintained high productivity rates across all studies I manage - Conduct all protocol training and ensure access to proper platforms of the staff for the studies I lead - RSV Vaccination Studies - Currently Leading the largest vaccination study at my site for the CRO Thermo Fisher Scientific. I am delegated to 2 additional RSV vaccination studies in which I am heavily involved in each - Lead and spearheaded the efforts and closed longstanding quality findings of sponsors and was able to secure the working relationship with our sponsors - Monitor the overall participant compliance through analysis and review of electronic data capture systems (EDC - Maintain all IRB Submissions and Source Data Agreements (SDA). This is to include continuing reviews that need to be submitted to the IRB - Maintain all paper and electronic regulatory binders - Ensured participants understand the requirements of the study and ensured correct execution of informed consent and visits - Responsible for the coordination and completion all of monitoring visits both remote and in person. This includes site initiation visits (SIVs), interim monitoring visits (IMVs), and close-out visits (COVs - Input and upkeep documentation for subject symptom surveillance per protocol - Proficient in lab sample collection and processing. Proficient in lab sample shipment for all clinical trials that I lead