Asheville Gastroenterology Associates has been involved in clinical research since 1996. We have participated in greater than 200 clinical research trials involving those of both pharmaceuticals and devices, and have served as an adjunct research site for several regional academic medical centers. Asheville Gastroenterology Associates is a large, single specialty group with partners who sub-specialize in all areas of gastroenterology and hepatology.
The research department’s mission is to bring the newest treatments to our patients and the region. We strive to meet study enrollment goals, provide excellent oversight by the investigators, and generate clean data while adhering to GCP and ICH guidelines. We are driven by intellectual curiosity, a desire to be involved in the newest treatments, devices, or techniques, and an obsessive attention to detail. Asheville Gastroenterology Associates is the largest gastrointestinal and hepatology research department in the state and one of the largest in the southeast. The vast majority of sponsors and clinical research organizations consider us a top site for integrity, enrollment, and quality of data.
We are a gastrointestinal and hepatology practice with 17 physicians and 7 midlevel providers and serve as regional referral center for advanced GI care in Western North Carolina. The department has participated in studies of Crohn’s disease, ulcerative colitis, irritable bowel syndrome, colon cancer screening, bowel preparation for colonoscopy, hepatitis B and C, drug induced liver injury, hepatic encephalopathy, gastroesophageal reflux disease, gastroparesis, biliary cannulation devices, and constipation among others. We maintain an extensive database of potential subjects for possible inclusion into trials.
Asheville Gastroenterology Associates Research Staff
William R. Harlan, III, MD, Director of Research
Dr. Harlan’s interest in clinical research dates back to medical school when he was the first Duke University medical student to do clinically oriented research during his third year. Serving as director and co-director for clinical research at Asheville Gastroenterology Associates for the past 17 years has allowed him to pursue his interest in clinical trial design and conduct while building the clinical research department. After receiving an undergraduate degree in public heath with a concentration in nutrition at UNC at Chapel Hill, he graduated from Duke University Medical School, followed by residency in internal medicine at Duke University, and fellowship training in gastroenterology at UNC Chapel Hill. He is board certified in gastroenterology and a member of the American College of Physicians, American College of Gastroenterology, and the Crohn’s and Colitis Foundation. Dr. Harlan and the other investigators maintain certification in CITI, NIH-GCP-ICH, and conflict of interest training. Dr. Harlan states “My goal for the department is to advance medical science and conduct clinical research that is intellectually stimulating and potentially beneficial to patients, while operating in an ethical manner with the utmost integrity.”
Roberta T. Golden, Clinical Research Manager x #3570
Our current Clinical Research Manager has been with AGA since 2008. She has 20+ years of combined medical, and pharmaceutical/management experience. She has a Bachelor’s of Business Administration degree and completed CRA training through Medical Resource Management. She also has diploma from AB Tech for clinical laboratory training. She is a certified study coordinator through the Association of Clinical Research Professionals (CCRC). Her research experience includes studies in Hepatitis-C treatments/HCV Registries/HCV RNA blood assays, Drug-Induced Liver Injury, Colon Cancer screening/DNA testing/device, Irritable Bowel Syndrome, Ulcerative Colitis/Proctitis, Crohn’s Disease, Non-Alcoholic Steatohepatitis (NASH), Hemorrhoids, Celiac Disease, Iron Deficiency Anemia, and more. She works closely with sponsors to acquire new clinical studies for the research department. She oversees a staff of 7 study coordinators along with a regulatory specialist, as well as completing feasibilities, initiating start-up activities, budgeting, and contracting for each study. She is certified to perform the Fibroscan procedure and has her CPR certification. Other certifications include IATA/DOT, CITI/GCP-ICH and COI training, as well as many sponsor provided electronic data entry programs/interactive web response systems/dairies, venipuncture and lab processing.
Alice D. Brunk, RN, Study Coordinator x #3562
Alice has been working in clinical research as a coordinator since 1997 and joined AGA in 2013. She graduated from Purdue University in pre-nursing and obtained her RN from St. Elizabeth Hospital School of Nursing in Lafayette, Indiana. Her research experience includes studies in Hepatitis-C (Treatment/blood assay), Iron Deficiency Anemia, Cardiology (Angioplasty, Coagulation, and Stenosis), Polycystic Ovary Syndrome, Arthritis, Staph infections and more. She is certified to perform the Fibroscan procedure. Current certifications also include IATA/DOT, CITI/NIH GCP-ICH training, as well as several electronic data entry/interactive web response systems/diaries as well as venipuncture/lab processing.
Kylee S. Diaz, Study Coordinator x #3426
Kylee has been working in clinical research as a coordinator since 2010 and joined AGA in 2012. She graduated from Florida Institute of Technology in Melbourne, FL, and completed the CRA Professional Development program through the Kriger Research Center. Her prior experience has also included working as an IRB coordinator. She is certified through SoCRA as a Certified Clinical Research Professional (CCRP). Her research experience includes studies in Hepatitis-C (treatment and registry studies), Celiac Disease, Non-Alcoholic Steatohepatitis, Ulcerative Colitis, and several cancer studies. She is certified to perform the Fibroscan procedure. Current certifications also include IATA/DOT, CITI/NIH GCP-ICH training, as well as several electronic data entry/interactive web response systems/dairies as well as lab processing.
Ann C. Jones, LPN, Study Coordinator x #3397
Ann joined AGA in 2014 but has been in research since 2006. She studied computer programming, and obtained her degree as a Practical Nurse from Carteret Community College. She has extensive experience as a coordinator and as an assistant manager of clinical operations through a large research center. She is also certified through the Association of Clinical Research Professionals (CCRC). Her research experience includes numerous trials for Rheumatoid/Psoriatic Arthritis, Lupus Erythematosus, Fibromyalgia, Diabetes, Irritable Bowel Syndrome, Ulcerative Colitis, Colon Cancer, and more. Current certifications include IATA (Saf-T-Pak), CITI, GCP-ICH, CPR, as well as multiple electronic data entry/interactive web response systems/diaries and venipuncture/lab processing.
Kelly M. Roberts, RN, Study Coordinator x #3427
Kelly has been working in clinical research as a coordinator since 2012 and joined AGA in 2013. She attended the University of Alabama-Birmingham and obtained her Associates Degree in Nursing from PHCC. Her research experience includes studies in Hepatitis-C, Iron Deficiency Anemia, Ulcerative Colitis, Crohns Disease, Cardiovascular, IBS-D, Diabetes, Osteoarthritis, and Asthma. She is certified to perform the Fibroscan procedure. Current certifications also include IATA/DOT, CITI/NIH GCP-ICH training, as well as several electronic data entry/interactive web response systems/diaries as well as venipuncture/lab processing.
Susan Westcott, RN, Study Coordinator x #3580
Susan has been working in clinical research as a coordinator since 2008 and joined AGA in 2011. She graduated from the University of Maryland-Baltimore with a Bachelor of Science in Nursing. She also has a Bachelor of Fine Arts Degree from Art Center College of Design in Pasadena, CA. She is certified through the Association of Clinical Research Professionals (CCRC). Her research experience includes studies in Hepatitis-C (Treatment/Registry/Low Platelet), Hepatic Encephalopathy, Compensated Cirrhosis, IBS-D, Crohn’s, multiple Cardiovascular, Diabetes, Hemorrhoids, and more. She is certified to perform the Fibroscan procedure. Current certifications also include IATA/DOT, CITI/NIH GCP-ICH training, as well as several electronic data entry/interactive web response systems/diaries as well as venipuncture/lab processing.
Christopher S. Childres, LPN, Study Coordinator x #3417
Chris has been involved with clinical research as a coordinator since 2009. He graduated from the Academy of Health Sciences in San Antonio, TX. And served 9 years in the Army as a Combat Medical Specialist and Licensed Practical Nurse. He has over 25 years of medical experience. His research experience includes clinical trials for Rheumatoid Arthritis, Psoriatic Arthritis, Lupus, Osteoarthritis, Fibromyalgia, Iron Deficiency anemia, and Non-Alcoholic Liver Disease. Certifications include: IATA, CITI/NIH GCP-ICH training, IV certifications with proficiency in venipuncture/lab processing. He also has training is several electronic data entry/interactive web response systems/diaries.
Shelly Wyatt, LPN, Study Coordinator/Infusion Nurse x #3340
Shelly joined AGA in May 2016. She obtained her degree as a Licensed Practical Nursing from Asheville Buncombe Technical College in 1989.She has an extensive background in geriatrics. She has been a clinical research coordinator since 2008, Certified through the Association of Clinical Research Professionals since 2010. Her research experience includes studies in Rheumatoid Arthritis, Giant cell Arteritis, Active Axial Spondyloarthritis, and Psoriatic Arthritis (PSA). Current certifications include ACRP GCP, CPR, Saf-T-Pak, Inc: IATA, Electronic Data Capture Systems: RAVE, INFORM, INTRALINKS, INFOSSARIO, TAO, ECW as well as electronic data entry/interactive web response systems/diaries, venipuncture and lab processing.
Cherie Putnam, Regulatory Specialist x #3388
Cherie joined AGA research in 2015 as our clinical research specialist. She has a BS in Health Administration through the University of Phoenix. Prior to coming to AGA, she worked as an IRB coordinator for the Institutional Review Board of a large local hospital. She is a Certified IRB Professional (CIP) through the Council for Certification of IRB Professionals. Cherie maintains all regulatory and Standard Operating Procedures documents for the department. Her other certifications include IATA/DOT, CITI/NIH GCP-ICH training, along with electronic regulatory submission platforms (IRB, IntraLinks, etc.).
If you are suffering from a GI disorder and would like to be considered for a research study, talk to your doctor, or e-mail us at email@example.com. Asheville Gastroenterology Associates is proud to offer its patients access to promising new experimental therapies not currently available. Our main office phone number is 828-254-0881. Also visit the current trials page for additional information regarding clinical research trials.