The founders of MCM and its Directors
of Clinical Research are Robert Cicero, Jacqueline Miefert,
and Pamela Miefert. The founders of MCM have over 24 years
of experience in conducting clinical studies.
Pamela
Miefert, RN, CCRA Director Clinical Operations
Pamela is a RN with extensive behavioral health and chemical
dependency experience. She has over 14 years experience
in clinical research. Pamela has been a monitor for
trials conducted nationally, as well as trained
staff in Good Clinical Practices, Code of Federal Regulations
and research ethics. She
has research experience in multiple therapeutic areas as well as
in negotiating
contracts and budgets with major pharmaceutical companies. E-Mail:pmiefert@mcmresearch.com
Jacqueline
Miefert, MS Director Regulatory and
Compliance
Jacqueline has over 9 years of experience in regulatory affairs. She earned a M.S. in Pharmaceutical Sciences from the University of Cincinnati and a B.S. in Business Management from Northern Kentucky University. She has
experience in several different therapeutic areas and
while working at a major academic center, she facilitated
multiple FDA audits with positive outcomes. E-Mail:jmiefert@mcmresearch.com
Patricia
Shay, CCRC Clinical Research Coordinator
Patricia is a certified research coordinator with over
11 years clinical research experience. She started as a
clinical trainer for Phase I trials and went on to coordinate
Phase II & III clinical trials as well as grants funded
by the National Institute of Health and the National Institute
of Alcohol Abuse and Alcoholism. Ms. Shay is a member
and is certified
through the Association of Clinical Research Professionals.
Ms. Shay has worked in several different areas of research
including Sleep Disorders, Alcohol Dependence, Smoking
Cessation, Fibromyalgia, Depression and other psychiatric
disorders. Ms. Shay is also a trained phlebotomist and
ECG technician. E-Mail:pshay@mcmresearch.com
Colleen M. Kennedy, PA-C Clinical Studies Sub-Investigator
Colleen is a NCCPA certified Physician Assistant with 9 years experience centered in GI, Hepatology and Liver Transplant. During her tenure at Mayo Clinic, Jacksonville, FL, she participated as a co-investigator on clinical trials involving new regimens for the treatment of chronic hepatitis C. Expertise in treating special populations led to the development of a Pilot Study aimed at improving response rates for HCV patients with end stage renal disease. Her hands-on management of patients listed for liver transplant resulted in the formulation of a titration algorithm that individualized HCV treatment based on patient stability and response. Colleen has been a Speaker in her field for several Pharmaceutical companies, as well as a faculty presenter and participant on National Advisory Boards. E-Mail:ckennedy@mcmresearch.com
Robert
Cicero, MBA Director Administration
and Finance
Bob is a formerly retired CFO and Company Officer of a
$160 million manufacturing operation. He has extensive
knowledge and 32 years of experience in finance, strategic
planning and administrative functions. He holds a Masters
in Business Administration from the University of Pittsburgh
and a BS in Accounting from Tri-State University. E-Mail:bcicero@mcmresearch.com
Susan
McSwiney Administrative Assistant
Susan has 12 plus years of experience in the
Administrative field working in the banking and insurance
industries. As the point of contact with MCM
Clinical Research, Susan is trained in minimizing placebo
response with study participants. She is responsible
for management of patient appointments including phone
reminders and follow-up. In addition to facilitating
intra and extra-office communications, she coordinates the
purchaeing of supplies and vendor services, and provides
data entry and management for MCM extensive patient
database E-Mail:smcswiney@mcmresearch.com
MCM Clinical Research LLC is affiliated
with board-certified, GCP trained physician investigators who conduct our
clinical studies.
Joseph
Kline, Jr, PhD, MD, MBA Principal Investigator -
Psychiatry
Dr. Kline is a board certified Psychiatrist that joined MCM as a principal investigator in 2008.
He obtained his doctorate in Physiology and Biophysics from the University of Louisville in 1983
before he received his medical degree from the University of Louisville School of Medicine in 1986.
He is a staff psychiatrist at Little Psychological Services PLLC in Florence, KY. Since joining MCM
in 2008, Dr. Kline has conducted studies in alcohol dependence, depression, migraines and schizophrenia.
E-Mail:jkline@mcmresearch.com
Corey Gallus, DO Principal Investigator – Family Practice
Dr. Gallus is a board certified Family Practitioner that joined MCM as a principal
investigator in 2009. He graduated from Wake Forest University and earned his medical degree
at the Chicago College of Osteopathic Medicine in 1997. Dr. Gallus completed his residency at
St. Elizabeth Medical Center in Kentucky. He currently serves as a member of the Summit Medical Board.
Dr. Gallus has an outpatient private practice that includes treatment of adults and pediatrics for a
wide range of diagnoses. Since joining MCM in 2009, Dr. Gallus has conducted studies in diabetes and depression.
E-Mail:cgallus@mcmresearch.com
Charles Breen, MD Principal Investigator -
Ophthalmologist
Dr. Breen is a board certified Ophthalmologist that joined MCM as a principal investigator in 2009. He earned both his bachelor (1983) and medical (1987) degrees at the University of Kentucky. Dr. Breen completed his residency at Louisiana State University. He is currently a member of the American Board of Ophthalmology, International Society of Refractive Surgery, Northern Kentucky Medical Society and the Kentucky Academy of Eye Physicians and Surgeons. Dr. Breen has an outpatient private practice that includes treatment of adults and pediatrics. Dr. Breen began conducting clinical trials in 2000. E-Mail:cbreen@mcmresearch.com
Michael E. Jones, MD Principal Investigator - Gastroenterology & Internal Medicine
Dr. Jones is a board certified Gastroenterologist and
Internist that joined MCM as a principal investigator in
2010. He earned his medical degree in 1997 from the
University of Missouri School of Medicine. Dr. Jones
completed his internship, residency and fellowship at the
University of Kentucky Medical Center where received many
honors. In 1999, he received the " Resident Research
Award" from the University of Kentucky. He is
currently a member of the Northern Kentucky Medical
Society, American Society of Gastrointestinal Endoscopy,
Crohn's and Colitis Foundation, Kentucky Medical
Association, American College of Gastroenterology,
American Gastroenterological Association, and the Society
of Internists. Dr. Jones has been in private
practice since 2003 at Tri-State Gastroenterology
Associates, PSC, a large group practice of eight
physicians. Dr. Jones has experience as a Study
Coordinator, Clinical Research Associate (CRA) and
Principal Investigator. E-Mail:mjones@mcmresearch.com
Martha Lee Walden, MD Principal Investigator - Psychiatry
Dr. Walden is a board certified Psychiatrist that joined MCM as a principal investigator in 2008.
She obtained her bachelor’s degree in Molecular Biology from Wellesley College before she obtained
her medical degree from the University of Louisville, College of Medicine in 1989. Dr. Walden completed her
residency at the Karl Menninger School of Psychiatry. She has been a practicing physician since 1994 and is
a staff psychiatrist at an outpatient practice that treats adults for a wide range of psychiatric disorders.
Since joining MCM, Dr. Walden has conducted studies in schizophrenia and depression. E-Mail:mwalden@mcmresearch.com