The Silberman brothers (co-founders of Clinical Research Fastrack) are passionate about improving the quality and progress of clinical research by educating well trained clinical research coordinators and sharing their talent with the industry. Clinical Research Fastrack’s program allows clinical research organizations to hire faster, train their team more effectively and complete studies more efficiently. Ultimately our goal is to help the industry answer the questions that our research is asking to unlock the cures to debilitating illnesses. Clinical studies are the gateway to bringing new and exciting treatments to help cure and prevent diseases ranging from cancer, heart disease, diabetes, Alzheimer’s, chronic respiratory diseases, influenza, tumors, septicemia, liver disease, Parkinson’s, obesity, arthritis and so many more. The Silberman brothers lost their mother after a long battle with Alzheimer’s disease and have a sentimental interest in finding a cure for this horrible disease that touches so many families. Too many of us have lost loved ones to fatal diseases and Clinical research Fastrack’s mission is to change the world by training coordinators that will find the cures to the illnesses that plague us and improve the quality of life for us all.
David Silberman, MPH
David Silberman is the CEO and Founder of Clinical Research Fastrack and a seasoned health education entrepreneur who has created and operated educational programs and non-profit organizations in Arizona, Texas and California. He also actively volunteers in his local community. David has the unique ability to develop strong organizations and construct vibrant communities. As a founder of National Laser Institute he built it into the largest medical aesthetics training center in the United States. At Clinical Research Fastrack his focus is on offering an engaging curriculum delivered by a team of experts who serve as passionate and knowledgeable instructors. Before founding National Laser and Clinical Research Fastrack, David held executive level positions at Health Ventures International in Scottsdale, AZ and at educational non-profit organizations in the San Francisco Bay Area. He earned his BA in Politics from the University of California, Santa Cruz, and a Master’s Degree in Public Health from University of California, Los Angeles. As a volunteer he presided as the Chair of the Board of Directors for the I Have a Dream Foundation-San Francisco. In one of his most challenging and rewarding volunteer roles he served as PTO Co-chair at his children’s elementary school where he helped to transform the school into one of the most sought after elementary schools in San Francisco.
Louis J. Silberman the Co-founder and Board Chairman of Clinical Research Fastrack is known for pioneering the medical aesthetics training industry over a decade ago with his vision to create National Laser Institute. National Laser trains physicians, nurses, aestheticians and and career changers in cosmetic lasers, cosmetic injections and anti aging treatments. Silberman was the first to market reinventing the medical aesthetics education space with short intensive programs. Silberman grew National Laser Institute nationwide providing training in Scottsdale, Dallas, Chicago, Boston, Philadelphia, Denver, Vegas, Nashville, San Francisco, Beverly Hills and Newport Beach. Silberman partners with Allergan (AGN on the NYSE) who is being acquired by Pfizer (PFE) for $160 billion. He also works closely with many publicly held laser companies who support National Laser Institute’s training programs. As the industry for medical aesthetic training has grown with hundreds of competing programs, National Laser is now held as the gold standard in the industry for quality and excellence and attendees fly in from across the globe to receive training at National Laser Institute’s. National laser also operates medspas within the educational facilities to provide a steady flow of clients for this national training institute seeing up to 3,000 clients per month.
Louis Silberman was also a semi-finalist for the Ernst and Young Entrepreneur of the Year Award 2014 (Prior award recipients include the founders of Google, Starbucks, Southwest Airlines, Dell and Amazon). He is known for starting Health4her.com, a women’s health and beauty retailer. Louis is a published author and nationally recognized medical aesthetics training expert, and a contributing editor for some of the country’s largest skin publications, including Skin Inc., Dermascope and Les Nouvelle. He is both an industry and motivational speaker at large venues nationwide. Louis has been written up in many publications including Entrepreneur Magazine, Business 99, The Business Journal, Internet Retailer, Woman’s World, E-merging Business, The Arizona Republic, Skin Inc., and Fortune Small Business.
Lauren Ballina, MS, CCRP
National Program Director
Lauren is a Pittsburgh native who graduated with a degree in Psychology and Latin from the University of South Carolina. She later earned her Masters of Biomedical Science from Midwestern University. She has several years experience as a study coordinator, working on both clinical trials as well as longitudinal observational studies. She has worked on both academic and industry-sponsored studies and has experience with study design, protocol development, study start-up, data collection and analysis, and publication. She served as a SOCRA certified Clinical Research Coordinator at The Mayo Clinic in Phoenix, AZ before taking the position of National Program Director at Clinical Research Fastrack. She is excited to have a leadership position with this growing team where she can help educate new individuals entering clinical research. In her spare time, Lauren enjoys cooking, hiking, and spending time with her family.
Jeannie Farnsworth, MS, BS, CCRP
Director of Outreach and Engagement
Jeannie graduated with a Bachelor’s degree in Biology and Biochemistry with a minor in Business Administration from the University of Nevada-Reno. She earned her Master’s in Clinical Investigations from MGHIHP in association with Harvard Medical School. She has over 17 years’ experience as a study coordinator, contractor, consultant, and monitor working on both drug and device clinical trials, predominantly assisting sites with study startup, protocol procurement, trial operations and staff training. Her experience ranges from pediatric endocrinology and diabetes to ophthalmology and neurology. Her love and respect for this industry stemmed from her cherished relationships with study patients in all stages and phases of research.
She has worked in a variety of settings across the research design process. She is currently the Senior Chapter Chair for the SoCRA Phoenix / Valley of the Sun chapter. She is thrilled to join Clinical Research Fastrack to advance the field and process of Clinical Research. In her leisure time, Jeannie enjoys hot yoga, paint nights, dining out with friends, and spending time laughing with her husband, four kids and beloved dog named Max.
Jennifer Kocour is an instructor at Clinical Research Fastrack and also serves as Sr. Director of Operations at Synexus Research, the largest integrated clinical research network in the world. Jennifer Kocour has worked with Synexus since 2006. During her tenure, she has been involved in many levels of operations within the company. She began as a research assistant, gained experience as a study coordinator and later managed sites as a Regional Director. Currently, she is the Vice President of Operations for the West territory. Ms. Kocour’s responsibilities include staff and investigator training, ensuring enrollment success and adherence to SOPs and industry guidelines. She holds a bachelor’s degree in Biology from Arizona State University and is a Certified Clinical Research Coordinator.
Graduate Services / Recruitment
CJ Anderson provides graduate services support to Clinical Research Fastrack. He is an ambitious business professional who embodies the entrepreneurial spirit that Arizona is known for. As the co-founder of Finding Pharma, Anderson led the successful launch of the Arizona-based placement agency, which offers a new take on recruiting. Finding Pharma connects the top 5 percent of candidates with the top 5 percent of employers in the pharmaceutical industry. It has been a labor of love for Anderson, who has always been passionate about helping others find fulfilling careers. As a college student, he often led workshops at homeless shelters to assist with resume creation and job search techniques. In addition to helping others develop their careers, Anderson has a passion for creating products and services that improve sustainability and facilitate community involvement. Anderson was one of the founders of Black Marlin, which offered college campuses an option to provide filtered water while reducing the global footprint of plastic water bottles. He was involved in sourcing the technology and building relationships with campus leaders to bring this concept to fruition.
Nancy is the Supervisor of the Clinical Research Department at the Mayo Clinic in Scottsdale, AZ where she manages a team of 25 researchers. She has practiced nursing for 19 years. Her clinical background is critical care and she has experience in Cardiology, Neurology, Pulmonary and Respiratory Care, Transplant, Gastroenterology, Hepatology, Hematology, Endocrinology, Nephrology, Orthopedics, Anesthesia Care, Radiology, Ambulatory, and Surgical Services. She started as clinical research coordinator 10 years ago and transitioned to a team lead and supervisor role. In this capacity, she is involved in all aspects of all clinical research projects from start up to closure, budget negotiations, contract, regulatory liaison, and as a point person for physicians. Her duties includes training, orientation, job assignment, ensuring budget timelines, hospital policy and good clinical practice are followed by the department. She has worked on over 100 clinical trials.
Sergio Guerrero, MD
Instructor / Consultant
Dr. Guerrero holds more than 20 years of experience in the clinical and medical research domain developing, managing, and coordinating activities related to multinational and multi-institutional clinical trials for the US and International biopharmaceutical/CRO/SMO industry. He has practical knowledge of many regional clinical research practices regulations, the Good Clinical Practices (GCP), Code of Ethics, and most current regulatory environment related to research in the US (FDA), Europe (EMA), and Latin America.
He has long-term experience working as a Director of an International Clinical Research Center at a Hospital setting where he has been responsible for managing a multispecialty investigator network within the hospital in most therapeutic areas to include endocrinology, dermatology, oncology, infectious disease, neurology, hematology, pediatrics, cardiovascular, and autoimmune diseases for drugs/biologics/medical devices; Director of a Clinical Research Center, where he was able to build a 32 bed phase I clinical research unit for Bioequivalence and Bioavailability studies in accordance with US FDA, the ICH/GCP guidelines and local regulations; Regional Director of Latin American for a CRO based in Raleigh, North Carolina managing clinical teams and medical researchers of multinational clinical trials; Director of an Site Management Organization (SMO) for the establishment of a local multi institutional research group and the administration of clinical trials;
He has been a key contributor to medical conferences and sits on several boards such as the Drug Information Association (DIA) in the US, and other international organizations that helps promote global training and professional development. He is presently a faculty member of the University of San Diego California and Utrecht University in Netherlands for the annual Clinical Research Certification and Clinical Trial Administration Programs, and other USA training consortia. He also serves as a scientific advisor and consultant in areas related to new local and international entities involved in the development of investigational new drugs, biologics and medical devices.
Dr. Guerrero Received his Doctor of Medicine degree from the School of Medicine of the Universidad Autonoma de Ciudad Juarez in Juarez, Mexico. He initiated his medical research career in Bethesda, MD (USA) participating in the organ/tissue transplant research technology development where he was responsible for coordinating and managing the operation according to the requirements of the Food and Drug Administration of the United States.
Amy Raymond, PhD, PMP
Amy was originally trained as a molecular biologist and has over 20 years of experience across all points of drug discovery and drug development. She has served as a field CRA on trials for neurodegenerative diseases such as ALS and Parkinson’s Disease and is now a Clinical Scientist on the Rare Diseases team at PRA Health Sciences, one of the world’s leading global CROs. In her current role, Amy provides full life-cycle support for clinical research trials in any of the 7,000 rare diseases, by providing sponsors with trial design and protocol considerations, training study teams in the rare disease indications, and contributing guidance throughout study operations. Amy enjoys continuing to grow as a clinical researcher, sharing her experiences, and helping expand the talent pool in the exciting and rewarding field of clinical research. As a graduate of the Clinical Research Fastrack program she is thrilled to return as an instructor. She is a member of SoCRA, as well as a board member in her local chapter of ACRP. Amy and her husband returned to Phoenix after more than 20 years away, and could not be happier to be back in the Valley of the Sun!
Sam Chimienti is an instructor at Clinical Research Fastrack and was recently promoted to a Clinical Trials Compliance Analyst after serving as Senior Clinical Research Coordinator at Phoenix Children’s Hospital. Sam was born and raised in Chicago and moved out to Arizona in his teens. He graduated from Arizona State University with a Bachelor’s Degree in Kinesiology and worked for 5 years as a Clinical Research Coordinator before being offered an amazing opportunity working with oncology patients at Phoenix Children’s Hospital. He is privileged to work alongside some of the top oncologists in the nation developing protocols for breakthrough drugs. He is also proud to have a co-authored a pediatric oncology protocol. In his spare time, he likes to do yoga, hike and try new restaurants.
Lisa Ince, B.S., CCRC, CCRA
Lisa Ince is a Sr. CRA at Syneos Healthcare Solutions (previously INC Resarch/inVentive Health. In 2016, she was named the Winner of the New Clinical Research Associate of the Year for the Americas by PharmaTimes. Mrs. Ince comes to Arizona from Chicago and has a bachelors degree in Psychology from Elmhurst College. Mrs. Ince has 12 years of experience in and has hed positions as a Clinical Research Coordinator, Clinical Research Manager, and Clinical Research Associate. She was Certified as a Clinical Research Coordinator 5 years ago and recently acquired her Certified Clinical Research Associate designation. Mrs. Ince is currently the Public Relations Coordinator for the Arizona Chapter of the ACRP and plans to start a Masters program in Clinical Research this year. Mrs. Ince spends her free time with her two sons and husband and enjoys swing dancing.
Kim Kundert brings years of experience to Clinical Research Fastrack as an instructor. As the Senior Vice President of Operations at at Synexus Research, the largest integrated clinical research network in the world, Kim was responsible for oversight of all operational activities at the site level. This included patient safety, enrollment on trials, and quality data. Kundert worked closely with all departments to ensure standardization across the sites. This means following consistent SOPs, source templates, QA processes, and standardized regulatory binders. Kundert holds a Bachelor’s in Nursing from Arizona State University where she graduated Summa Cum Laude.
Stephanie Althoff currently works as an In-House Clinical Research Associate for Pinnacle Oncology Hematology in Scottsdale. While obtaining a bachelor’s degree in Psychology with an emphasis in behavioral neuroscience, she began working in clinical research. It was this early introduction to the field that led Stephanie to her true calling. She has now spent more than eight years in clinical research covering everything from consumer products to genomics. She is currently working on her Master’s of Science from Drexel University in Clinical Research Organization and Management.
Dr. Nadira Trncic is an instructor at Clinical Research Fastrack. She brings a wealth of experience from working in medical field and research. She is a trained MD from her native Bosnia and Herzegovina, where she worked as a physician before leaving her country.
She started working in research in microbiology at Colorado State University in Fort Collins, and obtained her PhD in cancer treatment research in Radiological Health Sciences. Years spent in Veterinary Teaching Hospital at CSU, she was involved in clinical trials for pets with cancer and in Comparative Oncology before transitioning many years ago to human clinical trials. She is a Certified Clinical Research Coordinator and currently serves as a lead clinical research coordinator at Banner Research overseeing and conducting clinical trials. Her passion is in mentoring clinical research coordinators, helping organize staff training, helping in establishing structure that will support consistency and harmonization of processes across the teams.
Nadira enjoys working in a field where science is being translated into medicine, and bringing the opportunity to truly change people’s lives. In her spare time, she likes power walking and spending time with her family.
Meha is an instructor at Clinical Research FastTrack and is currently working on her masters in Clinical Research at the Arizona State University. She also serves as a Clinical Research Coordinator at the Mayo Clinic working on breast cancer trials. Her role includes patient enrollment, drug administration and data collection. She earned her bachelors in Psychology from the University of Arizona. In her spare time, Meha enjoys traveling and being outdoors.
Carly Benford is an instructor and writer at Clinical Research Fastrack. Carly currently serves at Director of New Site Development at Synexus Research, the largest integrated site network in the world. She is an experienced clinical research coordinator who has a passion to serve through thoughtful and effective management of research studies. She served as a coordinator at Translational Genomics Research Institute (TGen) in Phoenix, Arizona and began her career as a patient recruitment specialist and has advanced to her present position where she works with patients, physicians, scientists, and collaborators on a variety of studies. She graduated from Loyola University Chicago, where she was a student athlete, and was named an NFCA All-America Scholar-Athlete. While in college Carly was accepted into the Helios Scholars Program at TGen during the summer of 2010. She has coordinated clinical trials from study development to completion in the disciplines of genomics, oncology, women’s health, diabetes, Alzheimer’s, gastrointestinal, and others. Carly has advanced knowledge of state and federal regulations, as well as compliance with protocol guidelines. Carly lives in Glendale, Arizona, and her hobbies are CrossFit training, cooking, paddle-boarding and hiking.
Angie began working in clinical research in 2005 at the Naval Medical Center in San Diego, California, as a contractor for the Department of Defense in the role of a Prostate Cancer Research Coordinator. By 2007, she advanced into the position as a Clinical Research Coordinator Site Operations Lead at Naval Medical Center, in which she advanced the urologic research program through new, innovative developments. Before leaving the Naval Medical Center in 2011, Angie served as the Program Manager on multiple trials such as studies conducted on devices for arthroplasty in the military population. Previous to her current employment, Angie also gained a diverse range of clinical research experience working in clinical management roles for organizations such as the Jacksonville Center for Clinical Research and the East Coast Institute for Research. With over 13 years of industry experience, she currently serves as the Network Clinical Program Manager for HonorHealth Research Institute here in Phoenix, Arizona, overseeing the neurologic and spine research programs.
Sarah has over 17 years experience within the clinical research industry, serving in various patient-facing and leadership positions. She started her career as a Clinical Research Coordinator (CRC) at Physicians at the Peak in Phoenix, Arizona. For the next nine years, Sarah continued her work as a CRC working on trials in specialty areas such as: oncology, type 2 diabetes, neurology, osteoarthritis, endocrinology, in addition to several other disease specific studies. In 2011, she moved to Misawa-Shi, Japan, for a year to work for logistics company while traveling abroad with her husband. When she returned to the states she rejoined the clinical research industry working as a CRC at Premier Research in Phoenix. Since 2016, Sarah has served as a Site Manager for Radiant Research Inc. in Glendale, Arizona.
Trisha Raban is an instructor at Clinical Research Fastrack and also serves as the Director of Operations in the Phoenix area for Radiant Clinical Research, the largest clinical research organization in the United States. She holds a bachelor’s degree in Biology from Arizona State University and is a Certified Clinical Research Coordinator. Trisha Raban started working at Radiant as a research assistant in 2006 and since that time has been involved in many levels of operations within the company including study coordinating, and site and regional management. Ms. Raban’s responsibilities include training and recruitment of staff, providing oversight and guidance to staff, assisting in daily study activities, ensuring enrollment success and adherence to SOPs and industry guidelines.
Christina Chong currently works as a a RN Clinical Research Specialist for Banner Health in Phoenix. After obtaining a bachelor’s degree in Economics, she worked in the technology sector for a few years before deciding that healthcare – making a positive impact in peoples’ lives – was her true calling. Christina obtained a bachelor’s degree in Nursing from Arizona State University, and entered the Clinical Research profession. She has worked as a coordinator in a variety of for-profit and non-profit organizations for over 5 years in various indications including nephrology, interventional nephrology, Phase I oncology, Alzheimer’s, Parkinson’s and more. Christina is excited to share her enthusiasm and experiences in the clinical research profession blended with a financial and operational perspective. In her spare time, she enjoys hiking, cooking, tinkering at the piano, and playing board games with her kids.
Larissa Harrison serves as an instructor for Clinical Research Fastrack as well as the Director of New Site Development at Radiant Clinical Research, the largest clinical research organization in the United States. Larissa joined Radiant Research in 2012 as a Research Assistant and has since held roles as a Clinical Research Coordinator and Site Manager where she focused primarily on Type 2 Diabetes and Vaccine Trials. In her current role with Radiant, she leads and manages all aspects of developing new sites, training and mentoring new staff and establishing strategic partnerships. Larissa holds a Bachelor’s Degree in Psychology from Arizona State University.
Michaele started her journey in clinical research in 2002 when she began as a Clinical Research Coordinator for the Mayo Clinic in Scottsdale, Arizona. In this role she ran trials in areas such as: pulmonary, gastroenterology, neurology, dermatology, rheumatology, audiology, cardiology, and more. During her 15 years serving in this role, she developed a strong knowledge of proper GCP guidelines, federal regulations, and IRB policy. In 2017, Michaele transitioned from the patient-facing side and accepted the position of a Research Protocol Specialist for the Mayo Clinic. In her new role, she is independently responsible for executing the overall management of the clinical trial implementation, maintenance, and completion process. She is also tasked with providing consultative guidance regarding regulatory and policy requirements to physicians, study staff, and external sponsors, while assisting physician investigators with writing protocol.
Marie Collins, MHA, CCRP
Marie has been a part of the Mayo Clinic team since 2007, when she started as an Appointment Specialist within the Referring Physician Services department. It was in this role that Marie gained a deep understanding to the regulatory side of clinical research. Four years later, she moved into a patient facing position as a Clinical Research Coordinator within the Clinical Studies Unit. Between 2011 and 2015, Marie lead over 65 Phase II-IV trials in the areas of neurology, surgery, nephrology, and infectious disease. Currently, Marie serves as a Research Protocol Specialist at the Mayo Clinic where she independently executes the overall management of the clinical trial implementation, maintenance, and completion process. She is also responsible for completing coordination of study logistics/approvals, verification of content to meet institutional, industry, and federal standards. Marie regularly facilitates study feasibility in collaboration with principal investigators, and investigative study teams as defined by the availability of the subject population, personnel, funding, research testing facilities, space, and equipment.
Sarah Harvey is an instructor for Clinical Research Fastrack and serves as a Site Manager at Synexus, the world’s largest integrated clinical research site network. Her therapeutic areas of expertise include Cardiology, Women’s Health, Endocrinology, Gastroenterology, Genitourinary, CNS and Vaccine. Sarah was born and raised in Maryland and moved to Arizona in 2012. Sarah earned a Bachelor’s Degree in Sociology from Arizona State University. In her spare time, Sarah enjoys reading and spending time with her daughter.
Meghan Caldron is currently the manager of one of the largest sites at Radiant Clinical Research. She has been with Radiant since 2011 and has a diverse research skillset. Before Meghan assumed her role as a site manager, she was a regulatory coordinator followed by a clinical research coordinator. While she has experience in many different clinical indications, Meghan has an affinity for Type II Diabetes Management trials. She has an insatiable thirst for knowledge as demonstrated by her Associate’s degree in biotechnology, Bachelor’s degree in Health Sciences, and Master’s degree in Biomedical Diagnostics. She was recently admitted into ASU’s Clinical Research Management program which begins fall of 2016. Along with her academic pursuits, she enjoys drinking tea, travelling, reading, camping, and volunteering. Most recently, she was involved with Horses Help, an organization that serves the special needs population by way of therapeutic and recreational horse riding.
Catherine currently serves as a Site Director and was formerly a Certified Clinical Research Coordinator at the Muhammad Ali Parkinson Center-Barrows Neurological Institute of Movement Disorders in Phoenix, Arizona. In her role, Catherine is responsible for collecting accurate and proper information from participants of the clinical trial, while ensuring the appropriate protocol is followed. In addition to community recruitment and screening for trials, she verifies that the necessary informational forms are up to date and ready for review by the Institutional Review Board. Prior to becoming a CRC at Barrows Neurological Institute, Catherine served in the same position at Arizona Arthritis and Rheumatology. While working in the healthcare industry, Catherine has also gained tremendous experience as an educator working for St. Joseph’s Hospital and Medical Center and Cryo-Cell International.
Mindy is an instructor at Clinical Research Fastrack. She has a heart-felt passion for research. Starting her career at a small research company she learned everything from contracts to patient enrollment. Her clinical research experience is very diverse including indications such as HIV, multiple sclerosis & juvenile diabetes. She is currently a Clinical Research Coordinator at the Mayo Clinic in Scottsdale,AZ. Her primary focus is in the oncology department working on proton beam trials to improve radiation therapies. She enjoys research because it gives her an opportunity to learn new things every day and she enjoys patient interaction.
Stephanie has been working as a Certified Clinical Research Coordinator for over 10 years, and currently works at Banner University Medicine Neuroscience Institute in Phoenix, Arizona. She currently is managing over 12 trials in phases 2-4. In her role, Stephanie is responsible for developing research budgets, maintains site regulatory files, collects patient vitals, performs drug/device accountability, prepares protocols for local Institutional Review Board submission, in addition to numerous other duties. Prior to joining the Banner Health, Stephanie was a CRC at Barrow Neurological Institute at St. Joseph Hospital and Medical Center. Her extensive background also extends into lab science where she served as the Lead Research Technician at Barrow’s. During this experience, Stephanie coordinated many research experiments ranging from protein extractions to cryosectioning brain tissue.
Amy currently works for CSL Behring as a Clinical Oversight Manager. In her role, she trains and helps manage clinical research sites through proper protocols and regulatory readiness, and ensures appropriate Sponsor oversight. Amy also ensures that the CRA’s monitoring her research sites submit timely data and safety reports, while monitoring the forms of SOP’s, and ICH GCP guidelines. Previously Amy worked for GlaxoSmithKline Inc. as a Senior Regional Clinical Research Associate. As the lead CRA there, she developed study plans and agreements for site specific monitoring, as well as developed investigator meeting presentation materials. Amy was responsible for increasing the number and quality of investigator sites in the Phoenix Valley through research, networking, and relationship building, in which she identified 100+ investigator sites in the local/regional territory.
Kylie has seen almost every side of the medical and clinical research industry. She started as a Certified Nurses Assistant in Omaha, Nebraska, and became a Registered Nurse after graduating from Clarkson College. After three years as an RN, Kylie transitioned into clinical research working as a Clinical Research Coordinator. Two years later, she was a Senior Site Manager for Clinical Research Advantage Inc., at the same site she started at as a CRC in Iowa. In 2015, Kylie moved to Chandler, Arizona, to continue working as a Senior Site Manager for Clinical Research Advantage. In her role, she oversaw one trial site, ensuring proper documentation practices, staffing oversight, team planning and management, as well as maintain proper daily site operations. Last year, in 2017, Kylie took a position with Synexus in Phoenix, Arizona, as a District Director. In her role, she is responsible for many of the same duties, but on a larger scale. She oversees five trial sites and is in charge of maintaining communication with the sponsor/Clinical Research Organization.
Jill has an extensive business background and knowledge relating to the clinical research industry. She worked for Translational Genomics Research Institute (TGen) for over eight years as a Business Development Manager. In her role, she managed a $10 million budget within her division, built strategic launch plans for commercialization opportunities, in addition to reviewing and negotiating legal agreements and contracts. In 2011, Jill left TGen to work for HonorHealth Research Institute in Scottsdale, Arizona. She served as the Director of Operations for Clinical Research Programs for six years. In this leadership position, Jill oversaw multiple program budgets, increased the annual programs’ revenue by 10 percent per year, and represented the organization in negotiations with sponsors, agencies, and philanthropists. In 2016 she accepted the role of Director of Strategic Planning and Support Services for HonorHealth; in which she guides strategic planning and execution of business, operational, and marketing communication strategies.
Peter’s journey into the field of clinical research started soon after he graduated with a degree in biochemistry, from Arizona State University, in 2009. From there he went on to serve as a Study Technician for Covance Inc., located in Chandler, Arizona. During his experience, he served as head chemist on over 75 successful Early Development General Toxicology studies, in which he conducted in-depth analysis on pharmaceutical compounds. In 2012, Peter became a Clinical Research Coordinator at AZ Heart Rhythm Research Center in Phoenix. One year later, he accepted the role of a CRC II at Scottsdale Medical Imaging. There Peter coordinated and ensured proper day-today functions of the radiology, neurology, and oncology clinical research trials. In early 2016, he moved to the Mayo Clinic in Phoenix, serving as a Certified Clinical Research Coordinator for their staff. Here, Peter has served as the lead coordinator within the Cancer Clinical Research Office on numerous trials. Outside conducting subject visits, reviewing and submitting research findings to sponsors and Institutional Review Boards, Peter also serves in a teaching role to new CRC and ACRC team members.
Sandra Fleeman teaches a variety of courses in our program. Sandra has over 14 years of experience working in the Clinical Research Industry, and 15 years of experience working as a Registered Nurse Manager.
She currently works in gene and cell therapy in the osteoarthritis field. She loves the work she’s doing, and is excited to be a part of a new therapy that will impact people’s lives in such a positive way. Sandra loves clinical research because it is not only exciting, but it challenges her every day to learn and keep on learning. She began teaching for Clinical Research Fastrack because education is her passion, and she believes teaching with us is a perfect fit!
William Jones, CCRP received his degree in Health Education Interdisciplinary Biology and Music from Texas A&M. William has worked in research since 2003. He currently serves as a Clinical Research Educator at Children’s Health System of Texas. He started an in-person training forum called H.O.T. for Research (Hands on Training) for people in the field or new to the field to brush up on or learn new skills. William has worked on many trials and enjoys sharing his passion and exuberance for helping advance medicine through research. In his spare time he loves spending time with his wife and kiddos!William Jones, CCRP received his degree in Health Education Interdisciplinary Biology and Music from Texas A&M. William has worked in research since 2003. He currently serves as a Clinical Research Educator at Children’s Health System of Texas. He started an in-person training forum called H.O.T. for Research (Hands on Training) for people in the field or new to the field to brush up on or learn new skills. William has worked on many trials and enjoys sharing his passion and exuberance for helping advance medicine through research. In his spare time he loves spending time with his wife and kiddos!
Denise Hayes serves as an instructor for Clinical Research Fastrack as well as the Site Manager at Radiant Clinical Research Dallas Texas, the largest clinical research organization in the United States. Denise joined Radiant Research in 2011 as a Certified Clinical Research Coordinator. Her clinical research experience ranges from Phase 1 to Phase 4 clinical trials, and is very diverse including indications such as HIV, Rheumatoid Arthritis, Neurology, Endocrinology, Women’s Health, Gastroenterology, Osteoarthritis, Osteoporosis, Dyslipidemia and Vaccines to name a few.
Lawrence is currently a Clinical Research Manager at Children’s Healthcare of Atlanta, the largest pediatric hospital system in the Southeast. He holds a Master of Health Administration from Clayton State University. Lawrence started working in clinical research in 2003 as a Research Assistant and has worked varying roles at different institutions like the University of Zimbabwe and Emory University, and at hospitals including Grady Memorial Hospital and Children’s Healthcare of Atlanta. He brings in a wealth of research experience from managing drug and device trials in adult and pediatric research settings. Lawrence received his CCRC certification from ACRP in 2015.
North Carolina Instructors
Markedia is a Certified Clinical Research Coordinator Tier II for Duke University. She works with Principal Investigators/study teams to oversee the implementation and completion of federally funded and investigator initialed multi-site and sponsored studies. Markedia develops, coordinators, and manages clinical research studies conducted by PI’s at Duke. This includes the development of study procurements, management of research personnel, recruitment of applicable participants, and management of data collection and data entry. She also evaluates and interprets collected clinical data in conjunction with PI’s/study teams by preparing oral presentations or written reports that analyzes the progress and trends of the study. Markedia specializes in Stem Cell, Pharmacology, Mobile Health, and Veterans and Dementia Research.
Samantha currently works as an In-House Clinical Research Associate 2 for PRA Health Sciences in Raleigh, North Carolina. She obtained her Bachelors of Business Administration with a concentration in Management from North Carolina Central University. Upon graduation from college is when Samantha began her journey into the field of Clinical Research, landing her first opportunity as a Regulatory Document Specialist at the University of North Carolina at Chapel Hill. With now over 5 years of industry experience and a strong regulatory background, Samantha is looking forward to being an instructor and mentor, the same knowledge and passion that she encompasses for this industry.
Tippi currently serves as the Quality Assurance Manager for Raleigh Neurology Associates (RNA). She began her journey with RNA in the research department as a Clinical Research Coordinator in late 1999. She quickly recognized the desire to obtain her nursing degree, beginning with an Associate’s degree in 2005 and her BSN from the University of North Carolina at Wilmington in 2017. RNA is one of the largest private neurology practices in the country, with close to 60 providers and a robust research department conducting 35+ clinical trials at any given time. She has extensive knowledge in conducting Phase II-IV studies with a focus on Alzheimer’s disease, Multiple Sclerosis, Parkinson’s disease, stroke, sleep disorders, epilepsy, and migraine, in both the adult and pediatric populations. As the Quality Assurance Manager, she is responsible to ensure planning, coordination, and continuous improvement of processes and ensure methods are established and followed to control the quality of studies conducted at RNA.
Kelly transitioned from a healthcare educator into clinical research, and currently has over 23 years experience in the industry as both a Clinical Research Coordinator and Clinical Research Associate. From having extensive experience in site management and monitoring from qualification to initiation and close-out, she has also seen in query resolution and data cleaning in preparation for study closure. She is well-versed in development and implementation of study documents, including protocols, informed consent documents, patient retention/follow-up plans, and case report forms (CRFs). Some of Kelly’s areas of expertise include: oncology (breast and prostate), cardiovascular (hyperlipidemia and electrophysiology), rheumatology (arthritis), endocrinology (Prader Willi Syndrome), pulmonary (chronic obstructive pulmonary disease and asthma), infectious diseases (HIV), and central nervous (epilepsy).
Kristie has been in the field of clinical Research for the last 18 years and is currently the Site Manager for Endocrinology Research for the endocrinology department at Physicians East, PA in Greenville NC. She has worked on several pivotal diabetes studies such as Empa-REG, LEADER, and Devote Trials. She has also contracted with several pharmaceutical companies to assist with protocol development and feasibility studies from a site perspective as well as helped develop recruitment and retention initiatives. Outside of loving clinical research she is a workout junkie and a certified fitness instructor through AFAA and certified to teach 5 different Les Mills programs.
Myra is a pharmacist by education, and was first introduced to the clinical research industry while working at Ask the Pharmacist, a training and call center business. While there she worked as a Shift Manager/Medical Liaison whose responsibilities included training and overseeing personnel responsible for evaluating potential participants in breast cancer clinical trial. Her duties also included conferring with patients, the project manager, and team personnel in order to access subject/patient eligibility as well as verify medical history facts. This peaked Myra’s interest and she decided to leave retail pharmacy and work as a Clinical Research Associate monitoring clinical trials. Having worked as a CRA/monitor for 20 years Myra is familiar with sponsor and CRO expectations of site personnel.
Latasha Bailey is a Lead Clinical Research Associate at Duke Clinical Research Institute. She has over 10 years of research experience working in clinical research organizations, holding various clinical positions for Phase II-IV studies. She has experience coordinating activities as a Global and Regional Lead as well as working closely with other functional departments. Additionally, Latasha has successfully acquired and continues to maintain Certified Clinical Research Professional credentials (CCRP). She is an advocate for ethical research practices and quality assurance initiatives to ensure that patient safety and high-quality data are at the forefront of each project.
Lisa started her career in 2001 as an Environmental Quality Associate within a pharmaceutical manufacturing lab. This gave her an introduction to the manufacturing side of clinical research as her lab focused on quality control for investigational products used in clinical trials. From there, she progressed into a Research Associate role, similar to a Clinical Research Assistant. After working as a Research Associate for approximately 2 years, attending continuing education courses in clinical research and shadowing Clinical Research Associates within her company, she transitioned into her first CRA position. This role lead to a regional CRA position within the Clinical Research Organization world. While focusing on her clinical research competencies and professional goals, Lisa earned an MBA from University of Maryland in 2005. In 2008, Lisa moved into a Sr. Clinical Site Management position as a part of one of industry’s first client dedicated flexible resourcing teams, where she was able to progress into her role as a Line Manager. She has been able to train and mentor new CRAs in this position. Over the years, Lisa has worked with Phase 2 – observational studies with a wide range of therapeutic areas, in addition to being well versed in protocol and site management.
Jules is a dedicated, hardworking certified professional with 22 years of pharmaceutical industry experience with increasing responsibilities along his journey is clinical research. Oversight of monitoring has been my focal point for the last 8 years therefore, mentoring, managing, training and remediating site personnel and CRAs is his expertise. Some of the areas Jules has worked in over the years include the following: TMF file auditing, FDA regulation, ICH GCP, CRO/Vendor management training, and more.
John Carlos Diaz
John Carlos Diaz is the President and Owner of GeoSera Consulting, a Minority Business Enterprise that specializes in Clinical Research and Operations and executing Clinical Development Plans across multiple clinical trials. Prior to starting his own consulting company, John Carlos worked in Clinical Research for 10 years as a Clinical Operations Leader tasked with delivering endpoints within timelines and budgets. John Carlos has had various Clinical Operations roles with increasing levels of responsibility. Beginning at Merck in 2008, in Clinical Pharmacology through Cephalon/Teva managing phase I – IV, global, adult/pediatric clinical research from 2010 to 2015 and finally as the Clinical Operations leader for Braeburn Pharmaceuticals pipeline. Prior to entering the Clinical Research role, John Carlos was a Sr. Scientist at GSK within Drug Metabolism and Pharmacokinetics. After graduating from New York University in 2002 with a Bachelors in Biochemistry, John Carlos expanded his education base by obtaining professional certificates in Finance and Accounting from The Wharton School at the University of Pennsylvania, Clinical Research at Villanova University while finishing a Master’s degree in clinical research at George Washington University.
Jacqueline Louis is an instructor at Clinical Research Fastrack and serves as a Senior Clinical Research Associate at a top pharmaceutical company. She has 8 years of experience across the following projects Heart Failure- Phase Ib/2 NSCLC and UC, Heart Failure-Medical Device, COPD-Medical Device, Head Neck Squamous Cell Carcinoma and Multiple Myeloma II, Breast Cancer II, III, Bladder III, Renal I, Prostate II, Myeloproliferative Disorders III, Prostate IV, HIV II, Overactive Bladder II, III, Cardiovascular/Hypertension II, Respiratory/Asthma/Bronchitis II, III. Ms. Louis’ responsibilities include working remotely, monitoring for clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer commercial benefit. This may include the following site visits: qualification, initiation, interim, and closet out. She has experience working in Phases I-IV of Clinical Research Internationally and in the United States. She holds a bachelor’s degree in Biology from University at Albany and a master’s degree in Pharmaceutical Sciences from Long Island University.
Parth is an instructor for Clinical Research Fastrack and recently started as a senior CRA for ICON clinical research working on oncology studies He started his clinical research work as a fellow at Hackensack medical center working on department of defense and NIH studies related to Stroke, concussion and abdominal trauma. Shortly after he started working in the monitoring space, working contracts as well as joining Covance inc. as an oncology CRA for breast and prostate cancer studies. He graduated with a B.S. in Biotechnology from Rutgers University as well as a Doctorate in Medicine from Ross University. He was a trainer while at Covance and continues to observe and train new CRA’s at ICON.
Kathleen O’Malley is the Manager of Training and Education for the Jefferson Clinical Research Institute. In this role, she has designed and implement comprehensive educational programs, responsive to a broad spectrum of educational needs, with the ability to scale to the rapid expansion of Thomas Jefferson University and the Jefferson Health System. She is passionate about mentoring and guiding research personnel in conducting clinical research that meets the highest standards of compliance, integrity and scientific rigor. Kathy transitioned from fourteen years of high-risk, labor and delivery nursing to clinical research coordination in 2003, performing preoperative and ICU investigator-initiated research and industry sponsored clinical trials in the hospital setting. Ultimately, she expanded her experience and skills to incorporate all aspects of clinical trial project management. Kathy has a Bachelor’s of Science in Nursing, and is completing coursework toward a Masters in Clinical Research. She is a SOCRA certified clinical research professional (CCRP) as well as a Certified Childbirth Educator (CCE).
Cynthia Atkins, currently works as a Sr. CRA at a bio tech company, in Philadelphia. Cynthia has spent nearly a decade working in the pre/clinical research arena. After college, Cynthia taught in NY as a middle school ESL and math teacher. After years of teaching, she realized her longing for research, and development and wanted back in the industry! Cynthia, climbed her way through various positions and therapeutic areas. Learning and growing into an accomplished Sr.CRA Cynthia, is knowledgeable in all areas of study development, from study start up to close out.
In 2013 after graduating from Suffolk University with a biology degree, I began my career at Dana Farber Cancer Institute which first opened my eyes to clinical operations and research, something I quickly became interested in! After a couple years, I left DFCI and moved into more of a clinical trial consulting role, aiming to streamline the clinical trial process for research sites, sponsors and CROs. It was an incredible learning experience for me and ultimately is what led me to my role as Clinical Trial Manager at Tonix Pharmaceuticals in NYC. I am excited to be joining Clinical Research Fastrack as an instructor so I can help educate others about the opportunities that exist within this fascinating industry!
Our Admissions Department
Senior Admissions Representative
Dave has an incredible passion for helping students and professionals achieve their academic and career goals. He holds an undergraduate degree from the University of Arizona, while his post graduate studies culminated in earning his MBA. His 20-year career includes roles as Director of College Admissions and Vice President of Recruiting. Academically, David has personally assisted hundreds of U.S. and foreign students in earning full ride and six figure scholarships to such prestigious schools including Stanford, Vanderbilt, Carnegie Melon, Purdue, Xavier and Occidental. Professionally, David understands how challenging the process has become to begin a career in clinical research. Through our program at Clinical Research Fastrack, he helps recent college graduates and those “re-careering” to successfully navigate this new landscape. Some of the companies that David’s students are now enjoying incredible careers include: The Mayo Clinic, Covance, Synexus/Radiant Research, Jean Brown Research, Phoenix Children’s Hospital, UT Southwestern Hospital, Baylor Scott & White Health, Scottsdale Medical Imaging and Keystone Research. He looks forward to helping your career dreams in clinical research become a reality.
A native of Honolulu, Hawaii, Debbie came to the continental United States to attend Michigan State University, where she graduated with a degree in Hotel and Restaurant Management. After college she went on to work for Marriott International in California. Later, Debbie moved to Phoenix, Arizona, to complete a court reporting degree, and went on to work within the courtroom industry for several years. Debbie’s strong background in hospitality and relationship building, coupled with her passion for the possibilities presented by the clinical research field led her to joining our team. Her strong commitment to helping others, has fueled her desire to see a cure for Dementia/Alzheimer’s within her lifetime. Outside work, Debbie loves to cook, read, hike, spend time with her two sons, and walk her Great Dane, Sam.
Madison is a native of Iowa, and joins us just after completing her bachelor’s degree in communication and gender studies. During college she spent the majority of her time running clubs, doing documentary editing, and writing for various blogs. She also spent time assisting her own college’s admissions department by working in their call center to recruit more students. Before joining Clinical Research Fastrack, Madison did marketing and administrative work for community developers, non-profits, and colleges. She’s excited to learn about the new and exciting opportunities being offered by our program, and to help us grow. When she has free time Madison enjoys cooking and eating new foods, hiking, reading, and exploring all that Arizona has to offer.
Creative Marketing Specialist
Zach made the move from his hometown in Southern Illinois to join the Clinical Research Fastrack Team. He attended the University of Mississippi where he majored in Journalism. During his time in college, Zach served in various leadership roles including: President of the Society of Professional Journalists, Secretary of the Transfer Leadership Organization, and Copy Editor for his community college newspaper. Outside of work, Zach enjoys writing, photography, playing sports, and loves farm animals.
6th Grader and Future Fastrack All Star
Leila is an avid reader, strong soccer player, pianist and dancer. Not sure what she wants to do when she grows up, she is happy to support her Dad, Uncle and the entire Clinical Research Fastrack Team. Who knows… maybe she will be working at Fastrack one day?