At Wellstar, I maintain IRB and regulatory documentation for research studies, including protocols, amendments, and informed consent forms. I review serious adverse events and protocol deviations and help submit investigator-initiated studies for IRB or FDA review.
I use Good Clinical Practice and ICH principles in my work, support audits, and help follow up on corrective action plans. I also train and mentor newly hired or junior QA/Regulatory Specialists and contractors.
As a freelance graphic designer, I create images, illustrations, and logos for clients using Adobe InDesign, Photoshop, and Illustrator. Earlier, at Rare Disease Research, I supported regulatory and study startup work alongside administrative, HR, IT, and graphic design tasks.
