David SilbermanDavid 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. David has the unique ability to develop strong organizations and construct vibrant communities. As a founder of National Laser Institute, David helped build this company 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 Institute 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 the University of California, Los Angeles. In addition to his professional career, David has served as a community volunteer in which 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 Institute trains physicians, nurses, aestheticians, 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. He grew National Laser Institute to be nationwide, providing training in Scottsdale, Dallas, Chicago, Boston, Philadelphia, Denver, Las Vegas, Nashville, San Francisco, Beverly Hills and Newport Beach. Silberman partners with Allergan (AGN on the NYSE) and 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 Institute 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. National Laser Institute also operates medspas within its educational facilities. This national training institute sees up to 3,000 clients per month. Louis Silberman was also a semi-finalist for the 2014 Ernst and Young Entrepreneur of the Year Award (prior award recipients include the founders of Google, Starbucks, Southwest Airlines, Dell, and Amazon). He is also 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 about 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.
Jay Shubrook DO FAAFP, FACOFP
Dr. Shubrook is a Professor in the Primary Care Department at Touro University California. He also serves as the Director of clinical research at the College of Osteopathic Medicine. He has more than 15 years of research experience in clinical trials. As an investigator he initiated research at Touro University. At Ohio University he served as Director of the Clinical Division at the Diabetes Institute at the Ohio University Heritage College of Osteopathic Medicine (OU-HCOM) and Director of the University Medical Associates Diabetes/Endocrine Cente, both in Athens, OH. Dr. Shubrook serves as an associate editor of The Journal of the American Osteopathic Association (JAOA) His personal research focuses on early intervention in type 2 diabetes and improving care for people with diabetes. Dr. Shubrook characterizes himself as a “curious scientist. Every day I have more questions. The balance in my job allows me to see patients-which is why we do all of this work-generate more questions, and go research these topics. Then I can share what we learned with patients, students and professionals which is very satisfying.”
Mark S. Hanley is a business owner and an active community volunteer and VirTrial CEO. He served as the CEO of Radiant Clinical Research, a company he acquired in 2007. Since the acquisition, Hanley has built Radiant into the country’s largest wholly-owned network of clinical trial sites. A healthcare industry veteran, Hanley recently held a seat on the Board of Directors for Allied Healthcare International, a publicly-traded company, which was sold in 2011.
Prior to CRA, Hanley was the founder and CEO of O2 Science, a large regional provider of home healthcare products and services. Before that, he served as the senior vice president of sales and marketing for a national provider of infusion therapy services Coram Healthcare. Hanley is trained in emergency medicine (Paramedic/Creighton University) and began his healthcare career as a respiratory care practitioner for Methodist Healthcare Systems in his hometown of Omaha, Nebraska.
In his community, Hanley volunteers as a Court Appointed Special Advocate (CASA), a role that he has held since 2007. Appointed by Arizona’s Supreme Court, the mission of a CASA is to advocate for the best interests of abused and neglected children who are involved in the juvenile court system. Hanley has also served as a Republican Precinct Committeeman since 2008, and he has earned the distinctive title of Paul Harris Fellow from Rotary International and the Rotary Foundation.
Nancy Lizzul, RN
Lauren Ballina Chang, MS, CCRP
Lauren is a leading educator in clinical research who gained her experience conducting clinical trials at the Mayo Clinic as well as overseeing of longitudinal studies at UNC’s trauma center. She earned her degree in Psychology and Latin from the University of South Carolina. She also has her Master’s in Biomedical Science from Midwestern University.
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?
Jamaica is an Arizona native who obtained a B.S. in Care, Health, and Society with an emphasis in Social Work and Physiology from the University of Arizona. She has an extensive career history of working in behavioral health and hospice social work. Jamaica is also a Clinical Research Fastrack graduate who went on to conduct clinical research, specializing in Nephrology trials. At this stage, she was exposed to the vast structure of clinical research from study startup to closeout. The trials varied in complexity, primarily phase II-III, and included dialysis trials. Jamaica enjoys drawing, working out, spending time with her close friends, and taking her two dogs on adventures. Her drive for helping people and educating individuals about the impact of clinical research brought her back to be part of the Clinical Research Fastrack team!
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!
My name is Lauren Stockwell! I have a BS in Special Education Rehabilitation with a Rehabilitation emphasis from the University of Arizona! Fun fact about me is I am obsessed with all things Disney and love to eat carrots and tiramisu! My passion has always been helping people become the best possible versions of themselves and through Clinical Research Fastrack, I see that passion come to life. Clinical Research Fastrack is changing lives not only through our students but also through the individuals and families our students are impacting.
Bailey is a Montana native who has a background in Business Management and Data Analysis. She loves working at Clinical Research Fastrack because she loves helping students achieve their goals and succeed in the field of Clinical Research!
I love having the chance to help people make a huge change not only to their lives but soon to people who will become a part of their trials. When I am not working, one of my hobbies would be lifting weights so I can keep in good shape.
I graduated with a Bachelor’s degree in Public Health from the University of Arizona in May 2019. I am currently pursuing my Master’s degree in public health at Benedictine University. I have a passion for wanting to help others and leave the world a better place, so I am grateful I get to be a part of a company that does just that.
Laura is the Creative Director at Clinical Research Fastrack. She graduated with a Bachelor of Arts in Writing from the University of Tampa and formerly served as a writing tutor and a news editor. She loves working to help passionate people discover their goals and become equipped to help others through Clinical Research.
Liz is the Clinical Research Training Coordinator at Clinical Research Fastrack. She graduated with a Masters in Art Therapy from Buffalo State College and has worked in the behavioral health field as a therapist and clinical trainer. Liz is a graduate of Clinical Research Fastrack and has worked as a clinical research coordinator at Phoenix Children’s Hospital. She is passionate about empowering the students that enroll in Fastrack classes. To watch them grow and transform is humbling. They show you what is truly possible with determination and the right support. Liz finds herself leaving the day with a smile often, thinking back on their lightbulb, moments, or even just their jokes, and being honored by the connection we have made.
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.
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.
Jen brings a wealth of experience to our team, with over 13 years of sales experience in both the financial and pharmaceutical world. In her time with companies like Wells Fargo and AstraZeneca, she has developed new marketing/sales territories, and been a consistent leader in driving million dollar sale revenues. Jen enjoys spending her free time watching her two sons play baseball, conversing in her book club, and touring California wineries with her husband.
Edwin was born and raised in Honolulu, Hawaii. He earned an Associate’s Degree in Computer Networking and is an experienced licensed Journeyman Electrician. Edwin moved from Hawaii to Phoenix in 2013 to experience new adventures and opportunities and never looked back since then. Edwin is very family oriented as he loves spending quality time with his family. His hobbies and interests include traveling, playing sports and he has a deep appreciation for art and sneakers.
My name is Nick Heidenfelder! I have a Bachelor’s Degree in Sports Management and I worked as an Emergency Medical Technician before joining the Clinical Research Fastrack team. I love playing sports, exercising, cooking, and being outdoors. My life goal is to make a difference every single day to help make the world a better place and I love to help people accomplish their goals.
Andi is an Alabama native who holds a B.S. in Biology/Pre-Medicine from Florida A&M University and a Master’s in Contemporary Human Anatomy from Eastern Virginia Medical School. She has an innate passion for helping people and protecting the environment. In her spare time, she loves to challenge herself with art projects from painting to photography.
Takisha Adair has worked in the clinical research industry for over 10 years during which she has acquired wide-ranging experience relating to strategic project leadership, planning and management of clinical trials with responsibility for global clinical programs. She started her career working in Oncology research with a focus in cancer program accreditation. She became one of 46 Commission on Cancer trained consultants nationwide, receiving formal training at the American College of Surgeons in Chicago, IL. Following this, she moved into late-phase drug development programs holding various roles as a Clinical Research Associate for Clinical Research Organizations and Research Supervisor for Hospital System Research Institutes. In her role as a Clinical Operations Manager II at Covance, Inc., she was responsible for the day-to-day oversight of a one hundred bed Phase I Research Clinic within their Early Clinical Services Development Division. Takisha is currently the Director or Clinical Study Management at ProSciento, Inc. She is an active member of the Society of Clinical Research Associates (SoCRA) and serves as a guest speaker for several educational conferences on an annual basis.
Denise Hayes serves as an instructor for Clinical Research Fastrack as well as a CRA for Enterin, a Pharmaceutical company studying molecules and treatments for Parkinson’s. She was formerly the Site Manager in Dallas Texas at Synexus Research, the largest clinical research site network in the world. Denise joined Synexus (formerly 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.
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!
Sergio Guerrero, MD
Shane has been a clinical research professional since 2015. He specializes in heart failure medication and device trials. He also has experience with heart transplant and pulmonary trials. Shane’s clinical background includes 8 years of clinical experience in heart failure and advanced cardiac therapies.
Clinical Research Nurse with Site Management and Regulatory experience. Coordinated Phase I-IV trials in cardiology, oncology, allergy/asthma, rheumatology, gastroenterology, endocrinology, women’s health, vaccines, and other therapeutic areas. Skilled in FDA regulations, ICH, and GCP, IRB, EDC, and EMRs. BSN from The University of Texas HSC in Houston, RN licensed in Texas, CCRC certification through ACRP.
Amber S. Roberts
Amber is a Senior Associate at CSL Behring based in King of Prussia, PA. Prior to joining CSL, Amber spent the last 15 years in variety of roles including research compliance, quality, coordinator, and management roles in the areas of pharmacology, oncology, and neurology. Amber completed her Bachelor’s at the University of Arizona in Tucson, AZ, her Master’s at Temple University in Philadelphia, PA, and is currently working on her Doctor of Business Administration degree at Temple University. Prior to attending the University of Arizona, Amber grew up in Northern California and now calls Center City Philadelphia home. Amber enjoys visiting with friends and family, traveling, trying new restaurants, reading, and the performing arts.
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!
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.
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).
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.
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.
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.
Suzanne has her bachelor’s degree in Psychology and a master’s degree in Creative Arts in Therapy. She started her career working as a therapist in a community hospital on the inpatient acute psychiatric unit, dual diagnosis unit, detoxification unit, as well as the partial outpatient program and individual outpatient program. She has worked with all age groups, ranging from: children, adolescents, adults and geriatrics. Suzanne then went on to work for Eli Lilly as a pharmaceutical representative in primary care. For the past 17 years she has served as the Director of Research at Pearl Clinical Research in Pennsylvania. As director of a small site, Suzanne is responsible for all start up activities such as budget/contract negotiations and regulatory management. She also serves as the coordinator and rater on all studies. Suzanne has worked on over 100 clinical trials in many different therapeutic areas such as: cardiology, endocrinology, musculoskeletal, nephrology, urology, neurology, pulmonary, and respiratory diseases.
Maria is a Clinical Research Associate at PRA Health Sciences in Blue Bell, PA. Maria currently works in study start-up and conduct for Oncology trials. Prior to joining PRA, Maria worked as a Clinical Research Coordinator at the Hospital of the University of Pennsylvania. As a CRC, Maria primarily worked on Multiple Sclerosis trials in the Department of Neurology. Maria was involved in all aspects of the clinical trials, including budget negotiations, regulatory and IRB submissions, and patient recruitment and study assessments. While at Penn, Maria earned the Rising Star of Clinical Research Excellence award. Maria completed her Bachelor of Science in Business Administration with a concentration in Marketing from Shippensburg University. Maria grew up in Philadelphia, PA and enjoys spending time with her family and friends.
Elizabeth Del Mastro
Liz graduated from the University of Rochester in 2011 with a Bachelor of Arts in Psychology and a minor in Brain and Cognitive Science. During her undergraduate studies, Liz worked on multiple research efforts primarily investigating child development. After graduating, Liz worked as a Genetics Coordinator for a National Institute of Mental Health funded research program in Rochester, NY and then as a Clinical Research Coordinator in Dayton, Ohio. After relocating back to her home state of New York, she accepted a position as a Clinical Research Coordinator at Cardiology Associates of Fairfield County, P.C. In December 2016 she was promoted to Manager of Clinical Research and continues to oversee trial acquisition, budget and contract negotiation, training of all new employees, and day-to-day research operations. She is certified by the Academy of Clinical Research Professionals as a Certified Clinical Research Coordinator. She is excited to share her many years of research knowledge and insight through her participation in the Clinical Research Fastrack program.
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.
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.
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.
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.
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.
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).
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.
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.
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.
Kiki Diorgu, M.D.
Dr. Kiki Diorgu is a medical research professional with experience in both U.S and international clinical trials and regulatory affairs services. Dr. Diorgu currently serves as the Director of Clinical Operations for Morley Research Consortium, a full service CRO managing several multicenter and international clinical trials in the pharmaceutical and medical device industries. Dr. Diorgu has always had a passion for teaching. While in medical school, he was appointed as a teaching assistant to his peers in courses such as anatomy, physiology, cellular biology and biochemistry. He is the founder and lead instructor of a tutoring organization, Kikiprep, that provides educational services for medical students and medical graduates preparing to sit for the U.S medical boards (USMLE) as well as high school and college students preparing for tests such as the SAT, ACT and MCAT. Dr. Diorgu holds a Doctor of Medicine degree from Avalon University School of Medicine, currently lives in Atlanta, Georgia and enjoys playing soccer.
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.
Helen is a licensed, practicing pharmacist, certified clinical research coordinator and a Director of Clinical Research, with over 20 years of experience working with the pharmaceutical industry. Helen’s strengths are concentrated in developing research sites in various medical specialties and the training of coordinators and staff to meet FDA and GCP guidelines. Currently she is a CEO and Research Director of Clayton Eye Clinical Research, LLC, where she acts as a liaison between pharmaceutical sponsors, site monitors and site coordinators, initiates the review of protocols, establishes feasibility, and ensures compliance with industry guidelines without deviation. Other experiences include overseeing FDA audits, instructing in a clinical research course, and mentoring college students, research interns and coordinators.
Nikki currently serves as the Director of Research Programs for a non-profit, American Thrombosis and Hemostasis Network. There she is responsible for establishing processes to standardize and streamline the management of research programs at ATHN. She supervises project managers as well as collaborates with principal investigators on research protocols and publications. In her previous position at the Winship Cancer Institute at Emory University, Nikki successfully developed standard operating procedures, templates, and quality control forms. She has 13 years of experience in clinical trials within private practice, corporate, and academic settings. Nikki has worked in the clinical research community in the areas of: CRC, CRA, regulatory, and management. She has a MS degree in Industrial and Organizational Psychology from Capella University.
Wes Williams is a certified Clinical Research Coordinator working for Panda Neurology, and Atlanta Headache Specialists as the Clinical Research Operations Manager. He was hired to help build and train the clinical research practice, with focus in Epilepsy and Migraine in children and adults. Wes has an extensive background and knowledge of clinical research where he created business and marketing plans to enable research companies to grow in both profitability and organization. He enjoys mentoring and helping others grow in clinical research. Wes has over 10 years of experience in clinical research, and has worked on over 140 clinical trials in the following areas: glaucoma, cataract, retina, dry eye, eye lash growth, Meibomian gland dysfunction, diabetes, gout, hypertension, chronic obstructive pulmonary disease, vaccines, Alzheimer, migraine, Dravet syndrome, Lennox Gastuat syndrome, headache, migraine, Tourette syndrome, spasticity and ADHD. He plans to obtain his master’s degree in psychology in the next two years and start his own business.
Wenona Favors, a Certified Clinical Research Coordinator, is a Research Service Consultant with the Office for Clinical Research. Wenona started with the Office for Clinical Research in 2008 on the Post-Award team and later transitioned to the Education and Outreach team in 2011. Her present role supports educating and training Emory University’s clinical research staff on processes and procedures that support clinical research, however, she is primarily responsible for educating on Research Billing Compliance. Additionally, in her role she serves as a central resource for the research community to provide expertise and guidance on issues, mandates, and institutional policies related to human research protections. Prior to coming to Emory, Wenona worked as a Clinical Research Coordinator for Georgia Urology as well as a pain management clinic in Marietta, Georgia. She earned an MBA (with a concentration in Healthcare Management) from Brenau University in Gainesville, Georgia in 2016. She also currently holds a leadership position as Co-Chair with the Society of Clinical Research Associates (SOCRA).
Margo has an extensive background in the research and public health community. She had a strong desire to combine her passions of public policy and research, and went on to receive her Master’s in Public Health. During her dissertation studies on cancer screening she realized she loved the face-to-face interaction with the patient population. Margo currently serves as the Associate Director of Research Projects for Pediatric Nephrology at Emory University in Atlanta, Georgia. She is constantly reminded why she loves her line of work when she is able to mentor future researchers in understanding that healthcare is broad, and presents other opportunities outside the traditional nurse or medical doctor role.
Toks Onabanjo, M.D.
Dr. Onabanjo is a certified clinical research professional (CCRP) who specializes in project management. He serves as a consultant with the International Institute of Technology and Application. Dr. Onabanjo has several years of experience with in-house clinical research training, regarding proper site protocol and FDA regulations. He works closely with Principal Investigators to ensure that from the top down, that research sites are adhering to the right steps in delivering a safe and effective data collected clinical trial.
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 19 years of 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 and now serves in the regulatory department at Banner Health Research. She is also the Senior Chapter Chair for the SoCRA Phoenix / Valley of the Sun chapter. She is thrilled to teach at Clinical Research Fastrack to advance the field and process of Clinical Research.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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, and endocrinology. She also worked on several other disease-specific studies. In 2011, she moved to Misawa-Shi, Japan for a year to work for a logistics company while traveling abroad with her husband. When she returned to the United 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.
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.
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 began her career as a patient recruitment specialist, served as a coordinator at Translational Genomics Research Institute (TGen) in Phoenix, Arizona, 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 in 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.
Meha is an instructor at Clinical Research Fastrack and is currently working on her Master’s 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 Bachelor’s in Psychology from the University of Arizona. In her spare time, Meha enjoys traveling and being outdoors.
Dr. Nadira Trncic is an instructor at Clinical Research Fastrack. She brings a wealth of experience from working in the 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. She spent several years in the Veterinary Teaching Hospital at CSU, where 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.
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.
Kim Kundert brings years of experience to Clinical Research Fastrack as an instructor. Kim was the former Senior Vice President of Operations at Synexus Research, the largest integrated clinical research network in the world. In this role, she was responsible for oversight of all operational activities at the site level. This included patient safety, enrollment on trials, and quality data. She worked closely with all departments to ensure standardization across the sites. This means following consistent SOPs, source templates, QA processes, and standardized regulatory binders. Kim currently works as the Vice President of Clinical Operations at Virtrial.
Lisa Ince, B.S., CCRC, CCRA
Lisa Ince is a Senior CRA at Syneos Healthcare Solutions (previously INC Research/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 Bachelor’s degree in Psychology from Elmhurst College. Mrs. Ince has 12 years of experience in, and has held 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 Master’s program in Clinical Research this year. Mrs. Ince spends her free time with her two sons and husband and enjoys swing dancing.
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 co-authored a pediatric oncology protocol. In his spare time he likes to do yoga, hike, and try new restaurants.
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!
CJ Anderson is an ambitious business professional who embodies the entrepreneurial spirit that Arizona is known for. He is currently the President of Cognitive Clinical Trials a research site network focused on CNS trials. 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. 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.
Jennifer Kocour is an instructor at Clinical Research Fastrack and also serves as Senior 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 Western 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.
Kara Kronemeyer currently is a Clinical Research Coordinator for Bone Marrow Transplant in the Hematology/Oncology Department at Phoenix Children’s Hospital. In this role, she maintains Good Clinical Documentation, follows state and federal regulatory guidelines, consents and interacts with patients, and completes study budgets and billing reports. Recently graduating with her Master’s of Public Health from the University of Arizona in December 2018, she is looking forward to continuing to grow her research career. Throughout her five years of clinical research experience, she has worked on several investigator-initiated and sponsor clinical trials. Kara enjoys working in Bone Marrow Transplant as the field is constantly evolving.
Dr. Chloe Shay is the Senior Associate Director of Programs at Emory University. She received the Doctor of Business Administration Degree from Georgia State University and Executive Leadership for Healthcare Professionals Certificate from Cornell University. In the last 15 years, she has authored more than 40 peer-reviewed articles and book chapters in the fields of behavioral research and medical sciences and overseen numerous clinical trials funded by the federal government, institutions, and international pharmaceutical companies. Dr. Shay has always been passionate about teaching/mentoring clinical research professionals and helping others better understand various aspects of clinical research then improve with practice.
Harvonya is a Clinical Research Site Manager at BFHC. She earned her BS in Biochemistry from Texas A&M University. She has worked in clinical research for over 7 years and strongly believes that increasing the competency of coordinators will increase research opportunities and outcomes for everyone involved in the industry.
Gurpreet Brar, MD MDA
Gurpreet has worked in clinical research for over 15 years, having managed global project teams, clinical teams, and has experience as a study coordinator, field CRA, Clinical Team Lead, Project Manager and a Director in Project Management. He excels at global team leadership, risk management, and training and development of both project teams and site staff. He has either worked in or led global teams in all regions of the world. Gurpreet has extensive oncology experience, both as a CRA and Project Manager, having worked in Phases I-III in both solid tumor and hematologic malignancies. His strengths include supporting the patient recruitment and retention efforts and to help advise study sites in these efforts, as well as assist with managing any risks and training around the product reconstitution guidelines.
Gurpreet is multi-lingual across four different languages and holds a Medical Degree from Russia. He is based in Phoenix, Arizona.
Born in New Jersey, Atira spent much of her childhood in Virginia after her family relocated. She moved to Atlanta to attend Emory University, and earned a degree in Neuroscience and Behavioral Biology before going on to medical school. She unexpectedly fell into clinical research during a break in her education, and has been following the unplanned detour ever since. She worked with all aspects of the clinical research process, in private practice and academic medicine settings, with subject populations ranging from pediatric to geriatric. Her love of connecting with patients and enhancing their ability to engage with their clinical care remained a driving force in her career. She combined her love of educating with her desire to positively impact the future of clinical research when she became a Clinical Research Fastrack instructor during the inaugural class, and has been teaching with Fastrack ever since. Her personal commitment to continuous improvement and passion for optimizing all aspects of patient care recently led her to join the Javara team in her current role as Associate Director of Operations (Georgia), working to build an extraordinary culture of research innovation and advance access to research for all. Outside of her career, Atira loves spending time with her family – including 4 children, connecting with friends, cooking and baking, reading, dancing, and enjoying the great outdoors.
LaToya Hinton-Howery, MPH
LaToya Hinton-Howery, MPH is the CEO/Research Director of Next Innovative Clinical Research. She is a Medical Assistant by trade, holds a Bachelors degree in Health Administration and a Masters degree in Public Health. LaToya has 10 years of pharmaceutical clinical research experience in various therapeutic areas including Women’s Health, Dermatology, Gastrointestinal, Cardiovascular, Respiratory, and Oncology. LaToya aspires to continue educating medical professionals on how to break into the world of clinical research.
Joy graduated from Eastern Michigan University in 2010 with a BSN. She first worked as a cardiac critical care nurse and then a home healthcare nurse in the Detroit, Michigan area. Joy moved to Raleigh in 2013 where she started at Raleigh Neurology Associates as a neurological nurse. In 2016, Joy seized an exciting opportunity to move to the research department where she’s worked as a clinical research coordinator ever since. She also finished her MSN in Nursing Education this past March at UNCW. Joy is looking forward to combining her interests in research and education by instructing in the Fastrack program.
LaShoun Sanders: highly experienced Sr. Clinical Research Consultant with a demonstrated history of working in the pharmaceuticals industry. Skilled in Electronic Data Capture (EDC), Institutional Review Board (IRB), FDA GMP, Clinical Monitoring, Good Clinical Practice (GCP), and Trial Master File (TMF). Strong business development professional with a Bachelor of Science – BS focused in Health Care Management from American InterContinental University. Her main duties are site-management activities including: selection, initiation, training, interim, and close-out visits. Previously she served as a Clinical Research Associate and Clinical Research Coordinator.
Ms. Sanders has a broad research background across several phases of studies. Her experience is concentrated in the Cardiovascular, Dermatology, Endocrine, Gastrointestinal, Hematology, Immunology, Musculoskeletal, Neurology, Oncology, and Pulmonary therapeutic areas.
Kenneth Hall, Jr.
With a degree in Business Administration, over 5 years of medical device/life insurance sales, and 6 years of clinical research experience, I offer employers a wide range of experience and qualifications in many indications. My key focus at this time is bringing awareness to all people on the importance of patient participation in clinical trials and introducing upcoming college graduates to the clinical research field.
Charles Wright is a Senior Clinical Researcher with a career in clinical research lasting over 20 years. He managed the Patient Service Centers and technicians for over 40 sites for Labcorp. He subsequently moved over to Clinical Research Organizations monitoring, managing, and auditing clinical trials in the US and internationally. He partnered with pharmaceuticals companies to utilize his expertise in conducting clinical trials from Phase I through Phase IV adhering to ICH/GCP guidelines. Currently, he runs a private consulting firm providing project management, clinical monitoring, quality analysis and training for medical professionals.
Elizabeth Weeks-Rowe, LVN, CCRA, has 21 years of clinical research experience, including work as a study coordinator, CRA, CRA Trainer and CRA manager. She has been an Association of Clinical Research Professionals (ACRP), Certified Clinical Research Associate (CCRA) since 2004. She is a frequent speaker at clinical research industry conferences as well as a requested speaker at both ACRP and SOCRA local chapter events. She has written numerous articles for clinical research publications, such as ACRP, Centerwatch, Pharmatimes, Clinical Leader and the Journal of Best Research Practices. She also wrote the 2016 and 2018 updates to “The CRAs Guide to Monitoring Clinical Research” and the 2019 updates to “The PIs Guide to Conducting Clinical Research”, published by Centerwatch. She is a staff instructor for Clinical Research Fastrack, and works as a Principal CRA in study start up for Pharmaceutical Product Development (PPD), a global CRO.
Health policy professional by training; clinical researcher by trade; and patient advisor by necessity, Richie Kahn is intensely passionate about incorporating the passionate perspective to streamline clinical development and ultimately reduce the time it takes to bring promising new therapies to the patients that need them most.
Kasey Boynton brings over 12 years’ combined experience in the development and implementation of global clinical programs within CROs, academia and biotech companies. She has extensive experience in leading complex clinical protocols, cross-functional oversight and strategic execution that produces on-time results while fostering a highly-productive team environment. Kasey is a certified clinical research professional with extensive knowledge of ICH/GCP guidelines within the US, as well as governing authorities abroad. Kasey is based in Atlanta, GA and is an avid musician and fitness enthusiast.