Barbara Whitman, Regulatory Affairs Manager
Barbara has over 22 years of Regulatory Affairs and Quality Assurance experience in the medical device industry. She has worked with companies ranging in size from start-ups to large corporations, developing regulatory strategies for new and existing medical devices. Barbara has authored domestic and international submissions, obtaining global market clearances and approvals for all device classifications. She has created Quality Management Systems, ensuring device compliance spanning from concept development beyond commercialization to include post market activities.
Barbara’s medical device experience includes collagen vascular grafts, collagen skin grafts, electromechanical surgical staplers, neuromodulation devices containing software, electronic bio compression sleeves, and cardiac closure devices. She is motivated to help device companies assist their patients in the safest, most expeditious manner.
Barbara holds a Bachelor of Arts degree from Muhlenberg College in Allentown, Pennsylvania.
Jennifer Jones, Finance Manager
Ms. Jones has over 20 years of business and office management experience. Her expertise lies in accounting and bookkeeping. She has extensive experience with QuickBooks software. Jenn excels at organization and is extremely detail oriented. She is also experienced at employee and inventory management. Jenn has spent the last twelve years in the role of office manager for a small business where she was responsible for the management of all everyday activities and employees.
Jenn holds an Associate Degree of Business Management from Kent State University.
Kristie Williams, Government Affairs Manager
Ms. Williams has more than 20 years of experience in clinical trials with in-depth experience in all areas of research, including research operations, administration, clinical trial management, finance, human resources, and talent management. Her career in clinical research includes evaluation of submissions, awards, and agreements for compliance. She has provided pre-award and post-award guidance and processing of simple to complex research grants and contract applications, awards, and agreements.
She has extensive work experience with Institutional Review Board applications while working closely with the Institutional Review Board to oversee clinical trials. Ms. Williams breath of knowledge also includes an extensive knowledge in the design and implementation of Good Clinical Practices and Compliance in relation to clinical trials.
Ms. Williams holds a Masters Degree in public administration with a concentration in health care administration.
Sandra Gawlowski, Clinical Research Coordinator
Ms. Gawlowski has over 8 years extensive Project Management experience from concept to development to implementation in clinical research. Talents include in-depth knowledge of ICH guidelines, adverse event reporting, GCP auditing and coordination of a variety of clinical research studies.
She is well versed in study protocols, standard operating procedures, and general trial oversight.
Her quality of work is exemplified in the problem-solving ability and detail-oriented nature which is utilized in the effective collaborations with teams for successful production of clinical trials ranging from industry, cooperative, iiT, federal and NIH studies. Sandra specializes in establishing project objectives, developing experimental plans and effectively prioritizing tasks to meet time sensitive delivery goals. She has served effectively as a point person for executing phases I-III research projects and disseminating findings to leadership.
Sandra holds a Bachelor of Science from Arizona State University in Molecular biosciences and biotechnology and has extensively grown her career and passion for clinical research into a variety of successfully implemented and completed studies.