Our Team
The CMSU’s senior management team is comprised exclusively of professionals, each of whom bring with them over 20 years of experience from diverse roles (e.g. operations, clinical trials, QA, packaging development, regulatory compliance, drug development and project management) within the pharmaceutical and medical device industries. Our extensive industry experience combined with the resources available within a world-class academic research institution allow us to provide our clients with a uniquely integrated approach to delivering clinical strategy, packaging, labeling and logistics solutions and support for clinical trial programs or stand-alone trials, from proof-of-concept through Phase IV. Our distribution capabilities and project management experience ensure products are of the highest quality, delivered on time and to our clients’ satisfaction.
Senior Management
Cornelia Kamp, MBA
Research Associate Professor in Neurology
Executive Director Strategic Initiatives
Phone: (585) 355-5341
Fax: (508) 355-5349
Email: cornelia.kamp@cmsu.rochester.edu
Cornelia has served on the University of Rochester faculty for the past 20 years and has been the Executive Director of CMSU, in CHeT, since its inception in 2008. She received a Masters Degree in Business Administration (Operations Management and Finance) in 1994 from the William E. Simon School of Business Administration, at the University of Rochester. She has had more than 25 years experience in pharmaceutical-based research including: clinical drug/device supply services, project management, data management, operations, budgets, contracts, site management, and site activation. Cornelia has overseen the operations of more than 150 multi-center international clinical trials mostly in CNS and acute and chronic pain. She has managed over 23 INDs from initial submission through annual reporting and creation of the final Clinical Summary Reports (CSRs). She served as the Director of Clinical Research Operations at the Clinical Trials Coordination Center (CTCC) at the University of Rochester for more than 8 years and was formerly Vice President of Site Operations for SCIREX (now the Premier Research Group). She has served as a consultant to the Clintrex Research Corp, clinical research company that works with pharmaceutical organizations to operationalize development pathways for new treatments for CNS diseases, since its inception in 2010.
Eileen Fannon
Senior Director
Phone: (585) 758-0511
Email: Eileen.Fannon@cmsu.rochester.edu
Eileen received a BS in Biology from Lock Haven University. She joined the CMSU in June of 2022 and serves as the Director of Quality. She is responsible for the management, continuous improvement of and compliance to the CMSU Quality System. Eileen’s career did not start in the pharmaceutical arena, she served her country in the Armed Forces as an Air Force Medical Technologist and continued her education to be a surgical tech and provided nursing support on the labor/delivery floor. Upon an honorable discharge, Eileen’s pharmaceutical career started as a product development scientist at a small CMO – Contract Manufacturing Organization in Texas and quickly advanced to the Business Director where she supported numerous product launches; (development through FDA approval). Eileen relocated to Rochester, NY in 2002 where she continued her 20+ years of pharmaceutical and medical device experience at CellTech Pharmaceuticals as a Production Supervisor and moved quickly into senior management positions. A few of the management positions were at CellTech, UCB, and Unither Pharmaceuticals where she was the Director of Packaging / Production and Label Room Operations. Eileen’s career took her in several directions and provided opportunities in leadership, production, quality, packaging engineering and auditing. Over the course of the positions Eileen has held, it allowed her knowledge to grow in manufacturing, packaging, labeling design, supplier quality, project management, supply chain management, pharmaceutical packaging development, and supplier auditing. Eileen has led numerous cross-functional teams for a wide variety of projects including product development, pharmaceutical facility renovation, packing line implementation and equipment qualifications, new pharmaceutical and medical device packaging, supply chain efficiency and cost improvements and regulatory compliance initiatives.
CMSU Finance
Mary Lefebre
Sr. Staff Accountant
Phone: (585) 738-7145
Email: Mary.Lefebre@cmsu.rochester.edu
Mary joined CMSU in 2021. Previously she worked 13 years as the Accounts Receivable Manager for a private school bus company. Prior to that, she worked for a photonics company managing receivables, payables and payroll. Currently Mary is responsible for invoicing, collections and assisting with budget management for CMSU. She has a BA in English Literature from Nazareth College.
CMSU Operations
Christopher Mark, MS, MBA
Director, Operations
Phone: (585) 758-0508
Email: Christopher.Mark@cmsu.rochester.edu
Chris is a graduate of Rochester Institute of Technology (RIT) with a B.S. degree in Biotechnology. He began his career at the University of Rochester in 2008 in the Strong Memorial Hospital’s Microbiology lab performing diagnostic testing on clinical patient samples for bacterial, fungal, viral and TB infections. In 2013 Chris began working in the Department of Pathology & Lab Medicine’s Clinical Trials Central Laboratory where he took on positions of greater responsibility and authority, with his last position as Assistant Director of Technical and Scientific Affairs. He earned his M.S. in Medical Management in 2011, and his MBA with a Concentration in Competitive & Organizational Strategy, Business Environment and Public Policy in 2013 both from the University of Rochester’s Simon School of Business. Chris is a seasoned clinical trial expert with a proven track record of success, working on over 100 multi-center clinical trials with numerous trials leading to FDA approval. With nearly two decades of experience, he has a deep understanding of study design, kit creation, procurement, and inventory management. Chris joined the CMSU in 2024 where he currently serves as the Director of Operations.
Ellen Weinberger
Senior Operations Site Support Manager
Phone: (585) 758-0503
Email: Ellen.Weinberger@cmsu.rochester.edu
Ellen has been in the clinical trials industry for more than 25 years with experience at Pennwalt Pharmaceuticals, Fisons Pharmaceuticals and previously at the University of Rochester. For the last 13 years, she has served as the CMSU labeling supervisor, overseeing the production of all CMSU clinical labeling used to support drug and device packaging. Ellen has previously been a part of two clinical trial packaging start-up groups, in addition to coming in on the ground floor at the CMSU. Ellen was previously employed by The American Red Cross where she monitored hospital blood product inventory levels, ordering and shipping product when necessary.
Arian Horbovetz
Senior Clinical Materials Project Manager
Phone: (585) 758-0504
Email: Arian.Horbovetz@cmsu.rochester.edu
As a CMSU packaging technician for 13 years, Arian brings a wealth of practical knowledge to the table in his role as Senior Clinical Materials Project Manager. With an abundance of experience in packaging, clinical label design and creation, technical writing, visual aid creation and employee training, Arian brings a comprehensive perspective to study startup activities.
Jessica Larsen
Operations Site Support Specialist
Phone: (585) 758-0502
Email: Jessica.Larsen@cmsu.rochester.edu
Jessica joined the CMSU in 2017 and quickly became an integral part of the CMSU team. She has amassed extensive experience in Operations, Quality Assurance, Finance and clinical trial site coordination. She recently began training to support the production of the CMSU clinical labeling system. Jessica brings with her a wealth of audit and inventory control experience from her previous position.
Sean Weaver
Research Packaging/Facil
Phone: (585) 758-0516
Email: Sean.Weaver@cmsu.rochester.edu
Sean joined CMSU in 2022. With a background in Production and Quality Assurance in a manufacturing setting, Sean brings a wealth of knowledge of cGMPs, an attention to detail, and experience with paperwork verification.
Jose Carlos Gallegos
Clinical Supplies Operations Technician
Phone: (585) 758-0504
Email: jose.gallegos@cmsu.rochester.edu
Carlos came to the CMSU after 6 years at the URMC Labs processing clinical trial samples. His extensive experience with cGMPs, SOP writing and attention to detail make Carlos a new and welcomed member to the CMSU team.
CMSU Quality Assurance
Charcy Schultz
Director, Quality Assurance
Phone: (585) 350-3838
Email: Charcy.Schultz@cmsu.rochester.edu
Charcy is a graduate of State University of New York at Brockport with a B.S. degree in Psychology. She began her career at the University of Rochester in 2003 in the Sleep Research Laboratory running clinical trials for sleep disturbances. She moved over to the Wilmot Cancer Center at the University of Rochester where she continued to work on complex multicenter clinical trials and honed her expertise in this area. In 2012 Charcy moved out of the University to work at various GxP regulated Biotech companies focusing on improving health outcomes where she worked in the capacity of Project Manager and prominently in leadership roles such as Director of Quality and Regulatory Compliance. Charcy is well versed in Clinical Trials and Quality and Regulatory aspects of the GxP industry. Charcy has worked on over 100 clinical trials and has performed or been on the receiving end of over 300+ audits and inspections. With over 20+ years of experience, she brings deep understanding of Quality and Regulatory to the CMSU team. She has lead numerus teams in Auditing, Document Management, Regulatory, Validation, and Training Management. Charcy joined the CMSU in 2024, where she currently serves as the Director of Quality Assurance responsible for the management and compliance of CMSU’s Quality System.
Maricruz Vazquez
Research Quality Assurance Specialist
Phone: (585) 758-0507
Email: Maricruz.Vazquez@cmsu.rochester.edu
Maricruz (Mari) joined the CMSU in December 2019. Mari brings a wealth of experience from 13 years in the medical device industry (Ortho Clinical Diagnostics and LSI Solutions). In her 12 years at Ortho Clinical Diagnostics she supported the research and development of new diagnostic assays, as well as the validation of the final products. In addition to her analytical skills she brings knowledge and experience in biologic specimen handling and management, data management, document management, cold chain shipping, quality systems and auditing. Mari’s knowledge of GMP and GCP regulations & compliance and her understanding of customer needs and expectations through the life cycle of a product make her a valuable member of the CMSU team. Mari received her Bachelors of Science with Health Management degree in Dec 2023 and is continuing with a Master of Science and Health Management with primary focus on Research and Development from Robert Wesleyan University.
Maybeth Soto
Research Quality Assurance Coordinator
Phone: (585) 758-0558
Email: Maybeth.Soto@cmsu.rochester.edu
Maybeth comes to the CMSU from a larger industry where she held down diverse roles in the Quality and Operation departments. During her six years at LSI, she was responsible for the inspection and testing of manufacturing processes and products, as well as ensuring product quality and adherence to established company standards. She also helped generate reports of daily activities for executive evaluations. Her knowledge of quality policies, conducting inspections and presenting solutions makes Maybeth a welcomed asset to the CMSU team.
Travis Hurst
Research Quality Assurance Coordinator
Phone: (585) 758-0557
Email: Travis.Hurst@cmsu.rochester.edu
Travis joined the CMSU in January, 2023. With 10 years of experience in Processing, Packaging, and Quality Manufacturing, Travis brings great knowledge of SOPs, GMPs, and GDPs. With experiences in 5s, lean manufacturing, kaizens, internal auditing, as well as certification in Six sigma, Travis has led continuous improvement projects to increase production and efficiency. Travis is excited to join the CMSU team in 2023!
Bo Chen
Research Quality Assurance Coordinator
Phone: (585) 758-0506
Email: bo.chen@cmsu.rochester.edu
Bo joined CMSU at the beginning of 2024 as part of the Quality Assurance team. Prior to this role, he worked in Quality Control for a GMP-regulated biotech company based in Boston before returning to his hometown of Rochester, NY. Nearby in Geneva, Bo obtained his Bachelor of Science degrees in Biology and Psychology from Hobart and William Smith Colleges (HWS) in the spring of 2022. During his time at HWS, he was actively involved in Emergency Medical Services (EMS) with HWS EMS and Penfield Volunteer Emergency Ambulance (PVEA). Additionally, Bo has over 5 years of restaurant experience in service and management roles. He possesses the essential attributes of exemplary customer care and meticulous attention to detail vital for success at CMSU.