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Sarah Moeller, The Greenlight Group, LLC
Clinical Research History and Good Clinical Practices (GCP)
Post Market Surveillance / Risk Analysis - Audits - FDA and Competant Authority Inspections
Sarah Moeller is President and CEO of The Greenlight Group, LLC, a clinical research and clinical quality consulting firm based in Minneapolis, MN. Sarah has over 20 years of experience in clinical research auditing, monitoring, project management, 131 FDA inspections, site start-up, training, and quality systems work. Sarah has supported research on 6 continents in medical devices, pharma, nutrition, laboratory compliance and diagnostics. She worked together with colleagues to develop the St. Cloud State University masters’ program and curriculum in Applied Clinical Research and is an adjunct professor for the program. Sarah lived and worked in Brussels, Belgium for 3 years leading clinical research projects and FDA inspections. Sarah has a B.A. in neuroscience and classical piano from Macalester College and an M.S. in Integrative Physiology and Business Management/Entrepreneurship from the University of Minnesota. She serves on the advisory boards of the Minnesota Clinical Research Alliance, the Clinical Advisory Board of Medical Alley,and the French-American Chamber of Commerce, among others. She regularly cooks, just for fun, at several restaurants in Minneapolis and New York City and is a proud supporter of dog parks and the Animal Humane Society.
Paula Kamman, Principal Advisor, RCRI, Inc.
Topic: Clinical Trial Relevance in the Product Life Cycle
Paula Kamman is a Principal Advisor at RCRI, Inc. With over 20 years in global trial management within clinical affairs (both Pharma and Medical Device), Paula provides leadership as an overall project advisor and manager, serves as a strategic consultant and provides regulatory and clinical guidance both within RCRI, Inc. and with their clients. Paula brings many layers of expertise to clinical trials; with previous employment at various sized companies such as Eli Lilly-Europe, 3M Pharmaceuticals and Orphan Medical (start-up) and in addition with a former large pharma CRO, i3 Research. Paula has managed projects in a number of indications in support of PMAs, 510k, IND and NDAs. Her expertise is highlighted by clinical study management for both US only and global studies. Paula is grateful in finding a career that has proven to be always challenging, always changing and provides opportunity to never stop learning.
Mary Kay Sobcinski, Sr. Principal Advisor, Clinical Sciences, RCRI
Clinical Trial Design and Protocol Development: Critical Concepts for Effective and Efficient Trials
Study Activity Overview: Key Milestones for Trial Development, Conduct and Reporting
Mary Kay Sobcinski, RN, BSN, MHA, is a Senior Principal Advisor, Clinical Sciences, at RCRI. Mary Kay has extensive experience in clinical trial strategy development, design, and management; data management; medical product education; and medical product marketing. She has held management roles in both clinical and regulatory affairs for medical devices, biologic drugs, and combinations devices. She has authored numerous successful worldwide regulatory submissions for clinical trial and product approvals. Mary Kay has over 20 years of industry experience with an emphasis on cardiovascular, neuromodulation, spinal, gastrointestinal and infectious diseases indications as well as nursing and hospital administration experience. She has been a member of numerous multidisciplinary product development teams and has led many teams to successful project completion. She is a highly regarded speaker and educator. Her extensive medical product experience, nursing expertise and administrator background enable her to bring a unique perspective to strategic planning, project management, team development, problem solving and interdisciplinary communication.
Jill Tufano, Director of Client Services, Fortress Medical Systems, Inc.
Topic: Data Management - Case Report Form and Database Development
Jill Tufano is the Director of Client Services at Fortress Medical Systems. Jill’s role at FMS is to assist clients with their implementation of their EDC and CTMS system. This includes both system configuration and process development. Prior to FMS, Jill was a Principal Consultant and Founder of The Integra Group – a Minneapolis based CRO. Jill has a BS in biological sciences from Purdue University and for the past two decades has successfully managed clinical research projects with both medical device and pharmaceutical products, for small and large corporations alike.
Jill has implemented numerous efficiencies at clients by guiding them in the implementation of integrated and efficient process improvements and by maximizing the use of technology. Jill has significant expertise in Clinical Operations including study management, data management and monitoring. She has authored clinical protocols, designed case report forms, managed and monitored sites, designed, developed, and validated clinical databases, trained clinical personnel, supported regulatory audits, and contributed to multiple 510(K) and PMA submissions
Barb Duerr, 3M
Topic: Site Selection / Qualification - Site Inititaion and Training
Kari Loing, CCRP, Sr. Manager, Clinical Affairs, ValenTx
Topic: Sponsor Responsibilities - Investigator / Site Responsibilities, Delegations of Authority. Vendor Selection and Management: Core Labs, CROs, CEC/DSMB
Kari Loing is a Senior Manager in Clinical Research at ValenTx, a medical device start-up located in Maple Grove, MN. Over fifteen years ago, she made a career change from teaching science and math and returned to her initial interest in research. Her experience spans the breadth of working for tiny biotech companies to large medical device behemoths managing IDE, HDE, 510(k) post-market trials in both the US and abroad covering numerous indications. It seems like yesterday that she was new to the industry and attended Medical Alley’s Clinical Research 101 just like many of you today so she is thrilled to be back and close the circle.
Paul Below, P. Below Consulting, Inc.
Topic: Monitoring - Adverse Events and Safety Reports
Paul Below is the Managing Director of GCP Training Specialists, LLC, a clinical research training company based in Minneapolis metro area. Paul works during the day as a Principal Clinical Researcher/PMA Manager for the Urology and Women's Health division of Boston Scientific since June 2016. He is also an Adjunct Instructor in the St. Cloud State University Master’s Degree Program in Applied Clinical Research since 2010 where he has taught Lifecycle of Product Development, Clinical Study Design and Planning and Clinical Operations and Execution. Paul has been involved in clinical research for over 20 years and was previously employed as a Principal Clinical Research Specialist at American Medical Systems/ASTORA Women's Health and as a Clinical Research Associate at 3M Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, and Quintiles. Paul started his clinical research career as a study coordinator for a large multi-specialty private practice in Austin, TX. Paul is a Certified Clinical Research Associate with the Association of Clinical Research Professionals (ACRP) since 2001 and was a Certified Clinical Research Trainer with ACRP from 2008-2011. He was the President of the Minnesota Chapter ACRP in 2004 and 2010. Paul was awarded the ACRP Outstanding Leadership in Clinical Research as a CRA Award in 2011 and the ACRP Global Conference Top Speaker Award in 2012.