Morgan Inks Email & Phone Number

• Performs various study-start-up activities and maintains clinical study documentation for numerous pediatric and adult nutrition trials.• Designs Regulatory and Quality Control (QC) Tracking Systems to ensure essential document accuracy and completeness.• Initiates timely regulatory submissions and routinely conducts electronic Trial Master File (eTMF) reviews to validate audit readiness.

• Managed multiple sponsor-initiated drug trials for the treatment of glomerular disease, lupus, and vasculitis for the Nephrology Clinical Trials Unit. • Maintained regulatory compliance documentation, including delegation of authority and site training logs.• Built a series of EMR Data-Mining Queries using ICD10 codes corresponding to specific inclusion and exclusion diagnoses and procedures outlined in each study protocol to meet recruitment goals. • Implemented a quality system approach to ensure all source documentation is well articulated and thorough with the addition of a comprehensive checklist and visit record for each study-related visit. • Experienced in study start-up and feasibility tasks, as well as standardized CTCAE tools for adverse event reporting for sponsor-initiated and NIH-funded studies.

• Performed a variety of experimental applications in support of several vasculitis research protocols.• Enrolled 143 Subjects and processed laboratory specimens for the BAL Biorepository Protocol.• Conducted procedural assessments in compliance with the ICH-GCP guidelines and FDA regulations.• Identified abnormal test results and referred them to the Lab Director for further review.• Developed my laboratory techniques skillset using whole blood and THP-1 cell culture populations forFlow Cytometry, ELISA, and Western Blot application.Matthews, C. E. P., Fussner, L. A., Yaeger, M., Aloor, J. J., Reece, S. W., Kilburg-Basnyat, B. J., Varikuti, S., Luo, B., Inks, M., Sergin, S., Schmidt, C. A., Neufer, P. D., Pennington, E. R., Fisher-Wellman, K. H., Chowdhury, S. M., Fessler, M. B., Fenton, J. I., Anderson, E. J., Shaikh, S. R., & Gowdy, K. M. (2023). The prohibitin complex regulates macrophage fatty acid composition, plasma membrane packing, and lipid raft-mediated inflammatory signaling. Prostaglandins, leukotrienes, and essential fatty acids, 190, 102540. https://doi.org/10.1016/j.plefa.2023.102540 Fussner, L. A., Inks, M., Crouser, E. D., Me, W., Specks, U., & Gowdy, K. M. (2023). Anti-proteinase 3 Antibodies Augment Monocyte Activation and May Alter Monocyte Phenotype. ATS Journals. https://doi.org/10.1164/ajrccm-conference.2023.207.1_meetingabstracts.a6625