Management Staff
Stephen (Steve) Hope
Contract and Budget Specialist
Mr. Hope accepted his Clinical Trials Office position after having more than 20 years of healthcare experience including quality improvement and managed care. He worked as a consultant, before joining Cincinnati Children's, assisting local medical groups in the areas of practice management, strategy, contract management and negotiations. Prior to his consulting position, Mr. Hope spent three years with United HealthCare as a Manager, Network Management. He was responsible for provider education, professional relations and negotiating provider contracts including large and high profile medical groups, physicians of all specialties, ancillary and surgical centers. Other responsibilities included provider relationship management, establishing and maintaining fee schedules/budgets and cross-functional projects affecting providers and the way in which they run their business. Steve graduated from the Academy of Health Sciences in San Antonio, Texas.
Phone: 513-803-0772
Email: stephen.hope@cchmc.orgJane Howie, BS
Marketing and Recruiting Coordinator
Ms. Howie joined the CTO, after eight years of marketing and public relations experience in the non-profit field. Most recently she worked with Cincinnati Works, an organization whose mission is to assist people living in poverty move toward economic self-sufficiency through job readiness, employment and retention services. Ms. Howie increased community awareness of Cincinnati Works among its targeted member base, as well as potential funders and the community, through media coverage with a focus on public service announcements, publications and grassroots recruiting. Prior to her work with Cincinnati Works, Ms. Howie was a general manager for Babies R' Us, The Baby Superstore, with areas of expertise in recruitment, training and overseas and domestic apparel buying. Ms Howie has a Bachelor of Science degree in business, with a specialty in marketing from The University of Louisville. She provides marketing, public relations and advertising support to government, pharmaceutical and investigator-initiated Research Foundation studies requesting assistance.
Phone 513-636-0158
Email jane.howie@cchmc.org Jackie Hullfish, BS
Regulatory Affairs Coordinator
Mrs. Hullfish has more than 20 years of business, financial and management experience including six years of clinical research study experience. Her CTO duties include: preparing and submitting study protocols and informed consents to the IRB for approval, ensuring protocol amendments, adverse events and other required communication is conveyed to the IRB and study sponsors, and maintaining all the CTO's regulatory binders. Before joining the CTO staff, Ms. Hullfish held several positions at the clinical research organization Phoenix International Life Sciences (Cincinnati). Her titles at Phoenix included IRB coordinator, project assistant and data coordinator while working on more than 200 clinical studies. Ms. Hullfish has a Bachelor of Science degree in education from Morehead State University.
Phone 513-636-5872
Email jackie.hullfish@cchmc.org Pamela Jordan, BS
Contract and Budget Specialist
Ms. Jordan joined the CTO with more than ten years of experience with pharmaceutical research. Prior to becoming a member of the Cincinnati Children's team, she worked as a late phase specialist at Kendle International. Ms. Jordan has extensive experience establishing operating unit budgets through the analysis of historical data, future needs, and projected growth/sales of the business unit. In addition, she is skilled in ensuring that projects remain within set budget by performing budget vs. actual utilization analyses. She has also served as a marketing specialist and new business development project coordinator. Ms. Jordan received a BS in business and marketing from Oklahoma State University.
Phone 513-636-3203
Email pamela.jordan@cchmc.org Denise Maseck, RN, BSN
Research Nurse Manager, PPRU
Ms. Maseck joined Cincinnati Children's PPRU after spending 3 ½ years as primary nurse in the Pediatric Clinical Research Center at Children's National Medical Center in Washington, DC. Prior to accepting the position in the Pediatric Clinical Research Center, Ms. Maseck was a coordinator/manager for 6 years on the inpatient pulmonary and medical care unit at Children's National. During her research career she has coordinated and worked on approximately 100 research studies. Ms. Maseck received her RN/BSN from The Ohio State University.
Phone 513-636-0157
Pager 513-736-0978
Email denise.maseck@cchmc.org Melinda Muenich, RN, MBA
Business Director
Ms. Muenich joined the CCCR in Spring 2003 upon the opening of the outpatient research clinic and is currently the business director for the CCCR, Clinical Trials Office, Division of Clinical Pharmacology and the PPRU. She has been employed by Cincinnati Children's since 2001. Prior to accepting the business director role, she served as the education coordinator in the Division of Health Policy and Clinical Effectiveness where she was responsible for supporting evidence-based practice initiatives throughout Cincinnati Children's. Ms. Muenich has a diverse and extensive background in the health care industry including nine years of operations management, experience in business development, marketing, physician services, corporate health program development, and quality process improvement/design. She has also received specialized training in facilitation and process improvement tools. Ms. Muenich received her nursing diploma from the Deaconess School of Nursing, a BA in Communications from Xavier University, and her MBA from the University of Cincinnati.
Phone 513-636-7130
Email melinda.muenich@cchmc.org Mark Schuller, MA
Marketing and Recruiting Manager
Mr. Schuller has more than 25 years of experience in program coordination and development, administration, advertising, marketing and public relations in healthcare. This includes the past six plus years in the CTO helping to support hundreds of Cincinnati Children's research studies. He also has 15 years of experience at Hoxworth Blood Center, University of Cincinnati Medical Center, as Director of Marrow and Apheresis Recruitment/National Marrow Donor Program, Donor and Apheresis Coordinator and Assistant Director of Communications. Mr. Schuller has been a guest speaker at international and national clinical research conferences presenting on the topic of participant recruitment including the Association of Clinical Research Professionals. Prior, to his Hoxworth appointments, Mr. Schuller worked at two advertising/ public relations agencies including Young & Rubicam's Cincinnati office as a writer/account executive.
Phone 513-636-0314
Pager 513-736-0933
Email mark.schuller@cchmc.org Michael G. Spigarelli, MD, PhD
Assistant Professor of Pediatrics and Internal Medicine
Medical Director, CTO
Dr. Spigarelli, medical director, assistant professor of pediatrics and internal medicine, divides his time between the Clinical Trials Office (CTO)/Division of Clinical Pharmacology/Pediatric Pharmacology Research Unit and the Division of Adolescent Medicine. As medical director for the CTO, he serves as principal investigator and/or co-investigator for pharmaceutical clinical studies in the Division of Clinical Pharmacology and provides medical and research expertise for studies conducted at the CCCR. His research expertise extends to ongoing clinical studies supported by CTO study coordinators. He also provides publishing assistance and support for both completed and ongoing studies. Within the Division of Adolescent Medicine, Dr. Spigarelli serves as a clinician educator, with both patient care and teaching responsibilities. He is Fellowship Director in the Division of Adolescent Medicine and is committed to students, residents and fellows, helping to coordinate and facilitate development of their careers within the field of adolescent medicine and allied professions.
Dr. Spigarelli's educational background includes the completion of his fellowship in Adolescent Medicine at Cincinnati Children's Hospital Medical Center (2002). Prior to his fellowship, he completed his residency in Internal Medicine and Pediatrics at University of Michigan Medical Center, and attended medical school at University of Michigan Medical School in Ann Arbor graduating with a distinction in research. He carries board certifications in Internal Medicine, Pediatrics and Adolescent Medicine. Dr. Spigarelli also obtained his PhD in Medicinal Chemistry, in the design, development (including enantiomeric synthesis) and testing of novel therapeutic agents while at the University of Michigan, Rackham School of Graduate Studies.
His professional organization memberships include serving on the Multidisciplinary Membership Committee within the Society of Adolescent Medicine, the American Academy of Pediatrics, the American College of Physicians and Academy for Eating Disorders. He is responsible for numerous research publications, presentations and papers in the areas of eating disorders (anorexia nervosa, bulimia nervosa and related conditions), adolescent and pubertal development, adolescent gynecology, sexually transmitted diseases, preventative medicine and young adult care. Dr. Spigarelli continues to work with community organizations and remains actively involved with community health care activities and with other community-based organizations.
Phone 513-636-8597
Pager 513-670-4658
Email michael.spigarelli@cchmc.org Alexander A. Vinks, Pharm, PhD, FCP
Professor of Pediatrics
Director, Pediatric Pharmacology Research Unit (PPRU)
Director, Laboratory of Applied Pharmacokinetics and Therapeutic Drug Management (LAP-TDM)
Dr. Vinks holds an academic appointment with the University of Cincinnati, School of Medicine and is the principal investigator of the Pediatric Pharmacology Research Unit (PPRU) and director of the LAP-TDM laboratory and clinical pharmacology fellowship program at Cincinnati Children's. Before joining the Divisions of Pharmacology Research and Clinical Pharmacology at Cincinnati Children's OH (2000), he was director of the Clinical Pharmacology and Toxicology Laboratory, at The Hague (1986-2000). Dr. Vinks has spent more than 20 years in the field of Therapeutic Drug Monitoring and applied pharmacokinetics, both in the research aspects of population pharmacokinetic studies, as well as in the clinical application of these approaches to clinical patient care. His research interests include pharmacokinetic-pharmacodynamic (PK-PD) modeling and the application of population and simulation methods to TM and clinical study design. He has authored more than 50 publications in the areas of TM, pharmacokinetics and clinical pharmacology. Dr. Vinks is actively involved with the International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDM-CT). He is elected secretary of the Board and serves as chair of the TM cost-effectiveness committee. Dr. Vinks is board certified in clinical pharmacology and toxicology and is a fellow of the American College of Clinical Pharmacology. He is on the Editorial Board of Antimicrobial Agents and Chemotherapy, Clinical Therapeutics and Therapeutic Drug Monitoring. Dr. Vinks received his MS in Pharmacology from the University of Toronto Canada (1983) and a Pharmacy degree (1982) and PhD in Pharmacology (1996) from Leiden University, The Netherlands. He was trained as a hospital pharmacist (Pham, 1986) and clinical pharmacologist at The Hague Hospitals Central Pharmacy, The Hague, Netherlands.
Phone 513-636-0159
Pager 513-670-4369
Email sander.vinks@cchmc.org
