Lisa Terrett is a highly knowledgeable and respected clinical research manager with over 20 years of experience in the i...
Lisa A. Terrett Indianapolis, IN 46256 | Cell: 317.358.5656 | Email:
[email protected]
Clinical Trial Manager Highly knowledgeable and respected clinical research manager with over 20 years of experience in the in vitro diagnostics industry. Diverse technical background in clinical evaluations, research and development, and assay optimization. Management and team lead expertise with experience directing the activities of project teams engaged in clinical research projects to ensure compliance with protocols and overall clinical objectives. Experience in the fields of Medical Devices, Immunoassay, Clinical Chemistry, and Infectious Diseases.
AREAS OF STRENGTH
Clinical Trial Management Data review and interpretation Subject Matter Expert Informed Consent Documentation
Study Observation and Analysis Liaison between sites and Sponsor Clinical Team Leader/ Trainer IRB Coordination
Clinical Trial Monitoring Project Core Team Member Organized Record Keeping Dedicated, Committed
RESEARCH BACKGROUND 2006 – Present
Clinical Trial Manager/ Clinical Research Associate-Diabetes Care Clinical Evaluations Group Roche Diagnostics Operations|Indianapolis, IN Coordinate external clinical trials for new Point-of-Care devices. Devise study protocols, enlist clinical study sites, negotiate study budgets, train multiple study site personnel, monitor studies, and compose final study reports. Assume role of subject matter expert for product labeling and member of project core teams. Prepare and conduct multiple clinical trial initiation, monitoring, and close-out visits. Engage in the development of study protocols and case report forms. Serve as liaison between multiple study sites and project teams. Review study data for trends or concerns and assist with query resolution. Organize and present study data at business team meetings. Familiar with the use of Microsoft Project and ProChain Management software. Obtained FDA approval for over a dozen new products.
1998 – 2006
Research Scientist-Point of Care Testing, Roche Diagnostics Operations|Indianapolis, IN 2002-2006: Developed CoaguChek® test strips and controls. Planned test pilots for strips and strip packaging and established a new line of controls for CoaguChek strips. 1998-2002 - Improved drug abuse screening assays using dry chemistry technology (OnTrak TesTcup, TesTstik and TesTcard). Technical Lead for tricyclic antidepressant assay and Project Lead for RapidStrip™ low cost test strip project. Results of clinical trials provided for several new product launches.
1994 – 1998
R&D Scientist-Evaluations & Applications, Boehringer Mannheim Corporation|Indianapolis, IN Participated in the development of improved Clinical Chemistry assays and applications, including: Iron, TIBC, UIBC, Calcium, and liquid Alkaline Phosphatase methods. Added many new or improved assays to the company portfolio.
RESEARCH RELATED ACADEMIC ACTIVITY Graduate Research Associate, Food Animal Health Research Program, The Ohio State University, Columbus, OH Conducted research pertaining to the detection, cultivation, and pathogenicity of porcine pararotavirus.
EDUCATION MS, Veterinary Preventive Medicine, Focus: Microbiology & Immunology, The Ohio State University, Columbus, OH Thesis: Physicochemical Characterization of Porcine Pararotavirus and Detection of Virus and Viral Antibodies using Cell Culture Immunofluorescence BA, Biology, The College of Wooster, Wooster, OH
