Melaina Gautier

Accomplished Clinical Trial Manager with over 20 years of experience in clinical research, including executive roles such as Director of Clinical Operations and Vice President at a leading non-profit organization. Certified Clinical Research Associate (CCRA) since 2007, with deep expertise in CFR compliance, clinical trial management, site operations, and strategic project oversight. Renowned for ethical decision-making and strategic leadership, with a proven record of optimizing clinical operations and driving organizational success.

• Member of Association of Clinical Research Professionals (ACRP)
• INC Silver Star Award (2009), Performance Award for the Quarter as a Clinical Team Manager
• Perfect Attendance 2015-2019

• Infectious Disease
• Central Nervous System/Neurology
• Cardiovascular
• Endocrine
• Gastroenterology
• Pain Management
• Oncology
• Ophthalmology
• Device
• Phase I

• Infectious Disease Studies: Antibacterial Sinusitis, Phase(s): II and III, Date(s): 2002-2003, Role(s): CRA, Acute Exacerbation of Chronic Bronchitis, Phase(s): II, Date(s): 2002-2003, Role(s): CRA, Complicated Urinary Tract Infections and Acute Pyelonephritis, Phase(s): II and III, Date(s): 2005-2007, 2008-2010, Role(s): Lead CRA, CTM, (Pediatric) Otitis Media, (Pediatric) Otitis Externa, Phase(s): II, Date(s): 2002-2003, Role(s): CRA, C.Diff.Coloitis (CDAD), Phase(s): II, 2005-2006, Date(s): CRA, Sexually Transmitted Disease, Chlamydia, Phase(s) III, Date(s): 2008-2010, Role(s) CTM
• Cardiovascular Study: Hypertension, Phase(s): II ,Date(s): 2003-2004, Role(s): CRA
• Central Nervous System Studies: Schizophrenia, Phase(s): II, Date(s): 2002-2003, Role(s): CRA, Alzheimer's Disease, Phase(s): II-III, Date(s): 2005-2006, 2009-2010, Role(s): Lead CRA, CTM, Juvenile Bipolar, Phase(s): II, Date(s): 2000, Role(s): Research Assistant, Parkinson's Disease with and without Psychosis, Phase(s): I, II, Date(s): 2000, 2016, Role(s): Research Assistant, Contract Site Monitor/Manager, Diabetic Peripheral Neuropathy (disease modifying), Phase(s): II-III, Date(s): 2003, Role(s): CRA, Pediatric Tourette's, Phase(s): II Date(s): 2001, Role(s): Research Assistant, Role(s): CRA, Major Depression Disorder, Phase(s): I, Date(s): 1999-2000, Role(s): Recruitment
• Endocrine Studies: Diabetic Peripheral Neuropathy (Disease Modifying), Diabetic Neuropathy, Phase(s): III, Date(s): 2021-2022, Role(s): CTM, Diabetic Foot Ulcers (Medical Device), Phase(s): II, Date(s): 2001, Role(s): Research Assistant, Role(s): CRA, High Cholesterol (Hyperlipidemia), Phase(s): I, Date(s): 2015-2016, Role(s): Contract Site Monitor/Manager, Acromegaly, Phase(s): III, Date(s): 2021-2022, Role(s): CTM, NASH Disease, Phase(s): II, Date(s): 2021, Role(s): CTM, Cirrhosis, Phase(s): II-III, Date(s): 2021, Role(s): CTM, Liver Biopsy, Phase(s): II, Date(s): 2021, Role(s): CTM
• Pain Management: Rheumatoid Arthritis, Phase(s): III, Date(s): 2001-2002, Role(s): CRA, Osteoarthritis, Phase(s): II, Date(s): 2001-2002, Role(s): CRA, Ophthalmology, Phase(s): II-III, Date(s): 2001-2002, Role(s): CRA
• Oncology: Acute Myelogenous Leukemia Phase(s): I, II, Date(s): 2009, 2015-2017, Role(s): CTM, Contract Site Monitor/Manager, Breast, Phase(s): II-III, Date(s): 2008 ,Role(s): Lead CRA, Regional Manager, Ovarian, Phase(s): I, II, Date(s): 2010, 2015, Role(s): CRA and Contract Site Monitor/Manager, Multiple Myeloma, Phase(s): I, II,Date(s): 2010, 2015, Role(s): CTM, Contract Site Monitor/Manager, Prostate, Phase(s): II-III, Date(s): 2008, Role(s): Lead CRA, Regional Manager, Immunology, Phase(s): I, Date(s): 2015, Role(s): Contract Site Monitor/Manager
• Ophthalmology: Retina, Phase(s): II-III, Date(s): 2020, Role(s): Director, CRC, Glaucoma, Phase(s): II-III, Date(s): 2020, Role(s): Director, CRC, Dry Eye, Phase(s): II, Date(s): 2020, Role(s): Director, CRC, Presbyopia, Phase(s): II-III, Date(s): 2020, Role(s): Director, CRC, Ocular Hypertension, Phase(s): II, III, Date(s): 2007-2008, 2020, Role(s): CTM, Director, CRC, Cataract Surgery, Phase(s): II-III, Date(s): 2008, 2020, Role(s): CTM, Director, CRC
• Device: Diabetic Neuropathy Phase(s): II, Date(s): 2001-2002, 2009, Role(s): CRA, CTM, Cardiovascular, Phase(s): III, Date(s): 2001, Role(s): CRA, Ophthalmology, Phase(s): II-III, Date(s): 2020, Role(s): Director, CRC
• Vaccine: Adult MMR (Measles, Mumps, Rubella), Phase(s): I, 2016-2017, Role(s): Contract Site Monitor/Manager, Adult Tdap (Tetanus), I, 2016-2017 ,Role(s): Contract Site Monitor/Manager, Diphtheria Phase(s): I, 2016-2017, Role(s): Contract Site Monitor/Manager, Pertussis, Phase(s): I, 2016-2017, Role(s): Contract Site Monitor/Manager, Influenza, Phase(s): I, 2016-2017, Role(s): Contract Site Monitor/Manager, (Human Papilloma Virus), Phase(s): I, 2016-2017, Role(s): Contract Site Monitor/Manager

Outside of work, I enjoy spending quality time with my family, including watching football, basketball, and MMA with my two teenage sons and husband. I have a keen interest in stand-up comedy, reality shows, true crime, and documentaries. I am also an avid listener of audiobooks and podcasts. Additionally, I am deeply committed to community service, actively volunteering with school, church, and local initiatives.