Tracy Brainard Email & Phone Number

Morrisville, North Carolina, United States

• Designs, configures and builds moderate to highly complex web and/or phone based clinical trial applications.• Independently reviews clinical trial protocols and interprets Central Lab responsibilities based on protocol definitions and budgeted services.• Supports Project Management in the review of draft laboratory specifications document for consistency with protocol and budgeted requirements; provides feedback to the Project Manager regarding budget and/or protocol discrepancies, system design requirements, and/or concerns.• Advises Project Manager on procedural and budgetary items and the necessity for change due to database configuration requirements.• Ensures consistency of database design across sponsors and/or programs.• Configures Collection Flow Chart (CFC) based on protocol testing requirements, assay volumes, testing location, sample stability, and frequency of testing. Determines appropriate testing to sample allocation based on testing schedule, processing instructions, sample disposition, and third-party lab requirements.• Configures Kit Specifications based on protocol testing requirements, assay volumes, testing location, sample stability, testing frequency, study population, assay platform, total allowable blood volumes, sponsor/program requirements, as well as determining ancillary supplies.• Supports Project Management group with the development and implementation of the study database design modifications.

Morrisville

• Responsible for receipt, management and organization of all compounds received for client studies. Over 200 compounds are received monthly, not limited to multiple vials received of one test agent.• Created a new organizational system for accurate management of client compounds stored onsite; inventoried all compounds, returned or appropriately discarded compounds no longer needed, organized each storage area with new organizational bins, created a new form that is placed in all study folders that allows for better compound tracking when the studies are completed.• Collaborate regularly with Study Directors when discrepancies arise between shipping documents and protocols on study compounds and supplies.• Established an Excel inventory of all vehicle agents acquired to provide a proper inventory; to prevent over ordering; allow Research Technicians, Study Directors, and other departments to view what is available for study use.• Order and maintain inventory for expensive antibodies and standard agents; aliquot required amounts per each study, dependent on protocols.• Formulate client compounds for individual studies based on Compound Information Sheets provided by the client; formulate various vehicle components; provide aliquots and weigh outs to Research Technicians as needed.• Work with agents of various safety levels, from low level risk to class four and BSL2 agents.• Provide leadership and guidance to direct reports. Perform quarterly and yearly evaluations. • Interview and train new hires as needed. • Named ‘Key Contributor’ in 2016 for establishing a true formulation laboratory, where previously there was no definite group, or responsibility.• Currently the Morrisville Sustainability Champion. Attend monthly global meetings with other Champions. Provide ideas and input for Corporate initiates to reduce our Global Carbon Output; to be a leader in reduced environmental impacts. Provide activities during Earth Week/Day.

Morrisville, Nc

• Responsible for management of staff activities during the AM shift including company authorized personnel actions and mandated training and development. Assess and coordinate workload and assignments.• Project coordinator for client studies; coordinate study activities across shifts and ensure studies are performed on time and error free.• Provide leadership to research staff in the application of technical principles (e.g., metabolic background and knowledge to new internal studies), processes and disciplines.• Identify critical project-related issues and implement new methods and processes to resolve errors (e.g., improved process for critical morning dosing of all studies).• Collaborate with senior research staff on design, planning and execution of all research activities.• Execute client imaging studies using the In-Vivo Xtreme II™ by Bruker. • Provide critical in vivo support when needed, including monitoring cancer tumors, sampling and compound formulations.• Earned 2013 ACE Award for outstanding work with a Client, which included, troubleshooting, collaborating and executing a set of high-profile studies. • Named ‘Key Contributor’ in 2012 for executing a Client’s diabetes and metabolic studies.• Interview and train new hires.• Perform pre-clinical studies in oncology, maintaining an overall study workload of 200 – 700+ mice.• Knowledge and experience with multiple dosing routes and bio sampling methods.• Assisted and lead interactions with clients on face to face visits.

Responsible for the development and execution or rat telemetry studies supporting all Metabolic CEDD candidate selections. Established the use of treadmills as a model for exercise tolerance. Independently executed and designed the first rodent studies. Presented study specifics and outcomes to the Project Teams. Trained in mouse-gait analysis by Charles River Laboratories for locomotor function. Worked in a matrix team to validate the animal model for muscle function.Led and coordinated in vivo studies for the PPARpan project that supported selection of three candidates. Activities included compound formulation, dosing, collection of blood and tissues, data entry, analysis and presentation of data to Project Leaders, and record keeping. Participated in a matrix team which established a diet-induced obese marmoset colony for obesity studies in Metabolic Diseases. Performed Oral Glucose Tolerance Tests (OGTTs), collected blood for clinical chemistry analysis, and administered compound daily. Demonstrate solid technical expertise and working familiarity with a number of methods, techniques, laboratory procedures, and processes including: knowledge of mice, rat, dog, and marmoset animal models, and procedures such as IP, PO, IM, IV, SQ, capsule and dermal administration, euthanasia, tattooing, handling and restraint, temperature collection, blood collection, necropsy, aseptic techniques associated with rodent surgeries (ICV and telemetry), and detailed clinical observations.Execute a wide range of experiments independently based on protocols. (i.e., Acute and Chronic in vivo studies, OGTT's, IVGTT's, PK's, TK's, Irwin and DRF studies) Perform routine data management tasks including recording/tabulating results effectively in a laboratory notebook or computer and graphing data for presentations with no supervision.

Responsible for routine pre-clinical oncology studies.Perform basic and advanced technical procedures including: body weight collection and monitoring, tumor measurements, dose administration (all routes), documentation of clinical signs, tissue collection and compound formulation. Review protocols and study data and present in weekly meetings. Ensure protocol objectives and study endpoints are achieved.

Lead technician on GLP and non-GLP toxicology studies responsible for reviewing study protocols for accuracy and providing input on protocol development, scheduling the appropriate study events, and ensuring adequate staff was available to carry out study procedures. Ensured that adequate equipment and supplies were available and maintained to complete the necessary study activities. Reviewed the study data to ensure protocol objectives and study endpoints were achieved.Performed basic and advanced technical procedures including: body weight collection and monitoring, dose administration, food consumption collection and calculation, documentation of clinical signs, study events per GLP regulations.Authored several SOPs as needed.Investigated and validated the in vitro high throughput-screening assay for Genetic Toxicology.Scored micronucleus frequencies in mouse lymphoma cells.Have extensive knowledge in the use of biological safety hoods, analytical balance, microscopes, centrifuge, pH meter, hemacytometer, and the SOFTmax Pro, XFLUOR reader.Experienced in aseptic techniques, in vitro cell culture, and proficient at RNA extraction.Performed the comet assay, SOS/umu assay, MTS assay and CLOP Cytotoxicity assay.