Carol Beirne has over 27 years of experience at Abbott Laboratories in a variety of quality leadership roles, most recently as a senior manager in the Corporate Quality Organization. She has worked in both the pharmaceutical and medical device product areas. Beirne designed the management review procedure for the Diagnostics Division and represented the process and data to both internal and external auditors, including ISO and FDA. She has a bachelor of science in engineering that allowed her to be extensively involved in process improvements throughout her career. She led a division Quality Training staff in the Global Pharmaceutical Research and Development organization with employees in both Germany and the US. She has an ASQ Quality Manager/Operations Excellence Certification and has served in multiple roles in CAPA investigations. Beirne earned her International MBA from Keller Graduate College of Management.


Sheri Jacobsen has over 20 years of experience in the pharmaceutical research industry, having held multiple roles across all levels of industry including the areas of site investigation, clinical research organization and biopharmaceutical sponsorship. Currently, Jacobsen is responsible for ensuring that all functions supporting global pharmaceutical development at AbbVie have the training needed to execute clinical programs while ensuring regulatory compliance. She has an MA in clinical psychology with a concentration in neuropsychology from the Illinois School of Professional Psychology and a nursing degree.


Kimberly Rusk is the president of Optimyze Research, LLC. She offers a variety of consultative services to academic and community based clinical research organizations, as well as providing administrative support for the rigorous processes involved in conducting clinical research to both industry sponsors and investigators. Rusk has been involved in all aspects of clinical research for several decades, from delivering clinical care to research participants to developing comprehensive training programs and authoring and implementing quality assurance standards and procedures. She previously was the director of the Office of Clinical Research, at the University of Chicago. She received her BSN from the University of Illinois at Chicago and an MSHS from George Washington University.


Ruby Upadhyaya

Ruby Upadhyaya

Email Ruby Upadhyaya

Currently teaching:
Medical Device Regulations

Ruby (Sunita) Upadhyaya presently serves as the senior director of quality and regulatory compliance for North America at Arjo, overseeing post market surveillance, field quality, QMS & regulatory compliance for the region. At Arjo, Ruby is responsible for ensuring that products and solutions offered in the North American market are designed, manufactured & distributed to meet both the market needs and legal requirements. Her role covers multiple portfolios including patient handling, disinfection, diagnostics and prevention of pressure injuries and venous thromboembolism. In addition to healthcare, Upadhyaya has spent several years in electronic manufacturing, institutional research, and consulting organizations. Ruby has an MS in an allied field of industrial engineering (majoring in planning & forecasting) from DAVV University. She also has regulatory affairs certification in medical devices & pharmaceuticals from RAPS, PMP from PMI and has earned multiple ASQ certifications (CBA, CMQ/OE, CQA, CQE, CSSBB) thru the course of her professional career.


Lauren has over 15 years of experience in Hematology/Oncology clinical research operations spanning industry and academic healthcare. Her primary responsibilities include planning, organizing, directing, and overseeing daily operations for over 300+ therapeutic clinical trials within a section that accrues approximately 1200+ patients a year to interventional trials. Lauren assists in developing and executing strategic and operational plans (including fully integrated network sites) for clinical research, including new business practices and Standard Operating Procedures (SOPs). Lauren holds an MSc degree in Clinical Research Administration from George Washington University. In addition to her above-mentioned role, Lauren is an appointed Institutional Review Board (IRB) and Clinical Trial Scientific Review (CTRC) committee member at the University of Chicago. Prior to taking her role in the academic setting, Lauren worked at an Oncology CRO, Theradex, where she gained experience in clinical trial monitoring, auditing, and project management. Lauren traveled to several NCI-designated cancer centers to conduct site visit audits. Lauren has a strong passion for teaching and mentoring others about the exciting career opportunities in the field of clinical research.


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