Kathleen Kmiecik

Current Projects Providing services as the Senior Clinical Program Manager for Alterity Therapeutics 9/10/2023- present Multiple System Atrophy Previous Projects Providing Oversight and Monitoring Services for CSA Medical 11/1/2021- 10/16/2024 COPD with Chronic Bronchitis Device Trial Provided Monitoring Services for Functional Neuromodulation 8/1/2022-3/1/2023. Trial ended prematurely. Alzheimer’s Provided Monitoring Services for Sirtsei Pharmaceuticals, Inc 6/30/2020- 3/1/2023. Trial successfully completed. Major Depressive Disorder Provided Clinical Liaison Services for Allena Pharmaceuticals, Inc. 6/15/2021- 4/1/2022. Trial closed due to lack of efficacy. Enteric Hyperoxaluria Provided Monitoring Services for Empirical Spine 1/25/2021-5/1/2021. Trial closed due to lack of funding. Spinal Device for the treatment of Lumbar Degenerative Spondylolisthesis Provided Lead Clinical Monitoring Services and Project Management Services for Lungpacer 4/1/2019- 7/22/2020 Mechanical Ventilation Device Provided Monitoring and Lead Clinical Monitoring Services for Ora 8/21/2017- 7/22/2020 Retina Imaging trial, Dry-Eye Disease, Retinitis Pigmentosa, Acute Allergic Conjunctivitis and Center Involving Diabetic Macular Edema Provided Monitoring services for Auspex Pharmaceuticals 2/19/2014 –2/1/2018. Product received FDA approval Tardive Dyskinesia and Huntington’s Disease

Home Office Base- North Canton, Ohio 44720 • Served as a Lead CRA and monitor • Trained and co-monitored new hire CRA’s. • Services included source document creation, SOP development, Informed consent templates, chart review services, 483 correction plans, site development, site coordinator and staff training, development of clinical monitoring plans, audit preparation, budget negotiations, regulatory submissions and monitoring. • Co-monitor for new-contractors and monitors with high enrolling sites and provided updates to the sponsor following each visit including strengths, weaknesses and a plan for increased productivity. • Performed site management activities regarding the implementation, monitoring, and summarization of clinical trials to ensure adherence to protocols, GCP, ICH guidelines, federal regulations, and SOP’s. • Conducted site selection, site initiation, routine monitoring, and close-out visits for assigned studies. • Attended all investigator meetings. • Collected high quality clinical trial data from clinical study sites by specified timelines. • Developed and maintained collaborative working relationships with clinical investigative sites. • Managed sites in the US and Canada. • Direct communication with project management and sponsor representatives to ensure all issues were conveyed quickly and effectively. • Provided resolution of patient and protocol issues, deviations and waivers. • Direct relationship with the medical monitor to resolve all waivers, protocol deviation and patient questions and concerns. • Meet and exceeded all report submission deadlines as set by the Sponsor. • Meet all data base lock deadlines as set by the Sponsor. • Provided weekly reports regarding site initiation, enrollment and visit schedules. • Attended weekly sponsor calls • Provided weekly reports regarding site initiation, enrollment and visit schedules

Home Office Base- North Canton, Ohio 44720 • Performed site management activities regarding the implementation, monitoring, and summarization of clinical trials to ensure adherence to protocols, GCP, ICH guidelines, federal regulations, and SOP’s. • Conducted site selection, site initiation, routine monitoring, and close-out visits for assigned studies. • Collected high quality clinical trial data from clinical study sites by specified timelines. • Developed and maintained collaborative working relationships with clinical investigative sites. • Responsible for 8 protocols at 10 sites in Ohio with approximately 177 active subjects. • Phase 2 and Phase 3 studies. Therapeutic areas include Endocrine, Obesity and Cardiovascular. • One of five monitors selected to attend study start-up meeting in Denmark. • Member of committee to develop temperature deviation SOP. • Member of committee to develop standardized report templates for monitors. • Underwent 3 FDA audits without any minor or major findings. • Yearly underwent 2 QA internal audits without any major or minor findings. • Yearly underwent 2 manager audits without any major or minor findings. • Direct communication with project management and sponsor representatives to ensure all issues were conveyed quickly and effectively. • Provided resolution of patient and protocol issues, deviations and waivers. • Direct relationship with the medical monitor to resolve all waivers, protocol deviation and patient questions and concerns. • Meet all report submission deadlines as set by the Sponsor. • Meet all data base lock deadlines as set by the Sponsor. • Developed SOPs, source documents and clinical plans. • Attended weekly sponsor calls. • Provided weekly reports regarding site initiation, enrollment and visit schedules.

Home Office Base- Medina, Ohio 44256 • Monitored clinical trials and managed clinical sites within an assigned geographic territory to support pharmaceutical development programs in a manner consistent with ICH and PhRMA guidelines. • Responsible for 11 protocols at over 29 sites in the following territories: Iowa, Minnesota, Indiana, Ohio; Victoria and Vancouver, British Columbia; Calgary, Alberta; Saskatoon, Saskatchewan; and Winnipeg, Manitoba, Canada. On-site a minimum of 10 days per month. • Maintained a regional office. Managed activities in a time and cost-effective manner ensuring adherence to the budgetary guidelines and to ensure all project timelines and administrative obligations are met.

North Olmsted, Ohio 44070 • Specialized in site development and training, data monitoring, regulatory document management, and query resolution. • Assisted in the drug and device research process by working with sponsoring companies, contract research organizations, and investigators. • Conducted the following site visits: Initial site assessments, site initiations, periodic, enrollment support and close-outs. On site an average of 4-5 days per week. • Responsible for assisting the site with query resolution, site development and training and preparing sites for FDA audits. • Therapeutic areas include: Renal, Gastro-Intestinal, Cardiovascular, and Orthopedics • Participated in BIMO audits for multiple sites. • Created source documents and case report forms. • Reviewed informed consents for FDA and HIPAA compliance. • Trained research coordinators and physicians on study protocols and federal regulations/requirements related to clinical studies. • Provided support and assistance to over 55 clinical research sites. Acted as a liaison between the sites, the sponsor and CRO. • Developed company specific standard operating procedures. • Committee member for the following: Conference planning, FDA audit preparation, charity events, ethics, privacy policy and business development. • Assisted new monitors with training, both internally and for other companies. Attended monitoring visits to provide support and guidance. Completed report review for quality, content and accuracy. • Certified in Phase Forward. Received “Train the Trainer” certification. • Study load consistently included a minimum of 9 protocols. • Lead monitor for 5 sponsored studies and 6 physician-sponsored IDE’s. • Conducted the following site visits: Evaluation and inspection, briefing, periodic, site assessment and close-out. • Phase 2 and Phase 3 studies. Therapeutic areas include: Idiopathic and Neurogenic Overactive Bladder, Irritable Bowel Syndrome, Migraine Headache, Diabetic Macular Edema, M

Cleveland, Ohio 44109 • Collaborated with the PI and Co-Investigators to develop the Parents Advisory Group on Informed Consent (PAGIC). • Developed weekend conferences for Co-Investigators and parents of study Participants. • Performed literature reviews, conducted seminars at five U.S. sites, conducted face-to- face and telephone assessments, transcribed interviews, completed data coding and analysis, and participated in publication of research findings. • Developed assessment instruments, policies and manuals; trained parents, physicians and nursing staff in new intervention techniques, performed all pilot studies as needed and supervised employees throughout the project.

Areas of expertise include ADHD, and learning disorders, administration of intelligence tests and development of treatment plans. • St. Bartholomew, Cleveland, Ohio School Psychologist for 2001-2002 academic year