Opal Potter Email and Phone Number

•Coordinate and conduct clinical Phase I-III trials treating Metabolic Dysfunction Associated Steatohepatitis, Primary Biliary Cholangitis, Primary Sclerosing Cholangitis, Crohn’s Disease, and Eosinophilic Esophagitis•Demonstrate working knowledge and compliance with ICH-GCP guidelines, local SOP’s and regulatory agencies, as well as study-related and internal training and continuing education •Facilitate study feasibility, start-up, close-out, and on-study monitoring activities including managing relevant site visits, essential documentation, operational initiation with support teams•Interface with Sponsor/CRO and internal departments providing operational support•Perform detailed Informed Consents, eligibility review, screenings, and study visits •Facilitate timely review of test results and maintenance of thorough ongoing subject documentation and reporting of status, compliance, medical history, medications, and AE/SAE events. •Collaborate closely with Regulatory entities to ensure accuracy, efficiency, and timely execution of essential documentation•Assisted in routine Sponsor, CRO, and FDA Audits •Experience and knowledge in CTMS•Perform ECG, vitals, and phlebotomy•Handle laboratory processing and shipment •Develop and maintain Source Documentation and Case Report forms•Manage data entry and query reports through various databases •Maintain inventory of vendor equipment, laboratory supply, and investigational product•Manage site investigational product reconciliation, temperature monitoring, and reporting

•Coordinated and conducted multiple clinical Phase II-III trials treating Wet Age-related Macular Degeneration, Dry Age-related Macular Degeneration, Macular Edema, and Retinal Detachment •Coordinated and conducted Sponsor site visits including relevant start-up, close-out, and on-study monitoring activities•Assumed a regulatory role, which involved collecting, organizing, and submitting essential trial and IRB related documentation•Performed detailed Informed Consents, screenings, study visits, laboratory processing and shipment with facilitation of timely review of results, and thorough maintenance of subject documentation and reporting of ongoing status, compliance, medical history, medications, AE/SAE events and follow up.•Performed study-related procedures such as vitals, tonometry, and scribing•Developed and maintained Source Documentation and Case Report forms•Entered data into various databases and managed query reports for multiple Clinical Trials•Maintained study logs and inventory for laboratory supply and investigational product•Oversaw investigational product reconciliation, temperature monitoring, and reporting