Irene Mayo

Results-driven Clinical Research and Healthcare Operations Leader with extensive expertise in protocol development, clinical trial operations, study start-up, and strategic business management across phases I–IV. Proficient in managing pre-site selection visits, site selections, site initiation visits (SIVs), regulatory compliance, master service agreement (MSA) essential document collection, budget negotiations, and clinical trial agreement (CTA) execution. Strong relationship-building skills with principal investigators (PIs), sponsors, and contract research organizations (CROs) facilitate the delivery of high-quality results that meet FDA, ICH-GCP, and Advarra IRB standards. Demonstrated success in enhancing operational efficiency, optimizing patient recruitment strategies, and driving organizational growth through cross-functional leadership in healthcare, research, and business development settings.

• Reduced study start-up timelines by 25% through streamlined site feasibility processes and essential document collections.
• Achieved a 10% reduction in vendor contract expenses, saving $500,000 on a $5M budget by implementing milestone-based payment structures to enhance accountability and cost efficiency.

• Good Clinical Practice (GCP) Certification (ICH E6 (R2)-NIDA)
• NIH Human Subjects Research Training – CITI

• Clinical Trial Management & Oversight (Study-Start-up & Site Operations Management)
• Protocol Development (Support)
• Regulatory Compliance (Form FDA 1572, CV, Medical License, FDF, DOA, Training Log, etc......)
• Source Document Revision (Body and Language/Formatting)
• IRB Advarra Site Submission and Approvals Management
• IRB Advarra Protocol and ICF Revision and Approvals Management
• Budget & Contract Negotiations (CTA/Study Budget)
• Patient Recruitment & Retention Strategies
• Investigator & Sponsor Relationship Management
• Data Collection & Quality Assurance
• ECRF Amendments (GLG EDC)
• Risk Assessment & Mitigation (Site Recruitment, Protocol Deviations)
• Team Leadership
• Project Management (IRB Approved Marketing and Site Funding)
• AE/SAE and PD Procedures

• RADMAX Protocol: 01-06172024 – A Randomized Controlled Multicenter Trial, Examining the Effect of Derm-Maxx ADM on the Healing Rate of chronic Diabetic Foot Ulcers.
• A Phase III, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of BNT162b2, an mRNA-Based COVID-19 Vaccine, in Preventing COVID-19 Infection in Adults and Adolescents
• A Phase III, Multicenter, Open-Label Study to Assess the Safety and Efficacy of the RTS,S/AS01 Malaria Vaccine in Children at Risk of Plasmodium falciparum Infection
• A Phase III, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of CYD-TDV (Dengvaxia) in Preventing Dengue Virus Infection in Endemic Regions
• MED-MAXX Protocol: 02-070324 – A Randomized Controlled Multicenter Trial, Examining the Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcer.
• Cassava Protocol: PTI-125-09 - A Phase II study focusing on the treatment and diagnosis of Alzheimer’s disease using PTI-125 compound. It consists of two arms: a treatment arm and a placebo arm.
• Protocol: AL002-2 - A Phase I/II trial investigating the efficacy and safety of AL002 in patients with early-stage Alzheimer’s disease. This study includes a single Arm where all participants receive the experimental drug.
• Protocol: PTI-125-07 - A Phase III trial examining the long-term effects of the PTI-125 compound on Alzheimer’s patients. It includes three arms: a high-dose treatment arm, a low-dose treatment arm, and a placebo arm.
• Protocol: AH0003 - A Phase III clinical trial evaluating the treatment of hypertension with AH0003 drug. This trial has two arms: one for the experimental drug and one for the standard treatment.
• Protocol: CKJX839B123 - A Phase II study assessing the impact of CKJX839B123 on cholesterol levels in high-risk patients. The study is divided into two arms: a treatment arm and a control arm.