Date/TimeAugust 19, 2020
The impact of the ongoing COVID-19 Pandemic has driven global medical device Sponsors to perform everyday tasks and processes within a virtual setting. This has created several challenges for the device community, not the least of which is clinical trial conduct and management. However, the clinical research community, including Sponsors, CROs, study sites, Investigators and Institutional Review Boards (IRBs), has quickly adapted to a new, virtual environment to reduce potential negative impacts on subject safety and study integrity.
This virtual presentation and discussion reviews best practices and strategies to mitigate risk, minimize timeline impacts, increase site engagement and boost quality of remote clinical study management.
Participants will leave with a better understanding of:
- Protocol and supporting documentation development
- How a virtual environment increases flexibility
- Communication considerations between sites, Sponsors and CROs
Jason KrzeszakPrincipal Product Development Strategist
Jason Krzeszak has 15 years of experience in product development of medical devices and joined NAMSA in 2018. Jason has led activities focusing on preclinical and clinical research of devices through the feasibility, premarket and post-market phases. Notably, Jason has held leadership positions within clinical affairs for both large and start-up companies, which also included cross-functional leadership responsibilities. He has clinical experience in vascular (cardiac, aortic and peripheral vascular), cervical spine and urinary stones, in addition to numerous applications of medical technology in the preclinical environment.
Nicole TierneyPrincipal Clinical Research Associate
Nicole has over twelve years of experience in both pharmaceutical and medical device clinical research. Prior to joining NAMSA, she was a Clinical Research Coordinator in the fields of neurology, allergy, asthma and chronic obstructive pulmonary disease. She holds a B.A. in Biology from the University of Northern Iowa and is a certified Clinical Research Coordinator (CCRC).
Jamie SeifertSenior Clinical Research Associate
Jamie has over nine years of experience in medical device clinical research. Prior to joining NAMSA, she supervised clinical research operations within a large healthcare institution and at a small start-up company conducting a global IDE PMA study. She holds an M.S. in Applied Clinical Research from St. Cloud State University and a B.A. in Mass Communications from St. Cloud State University.
Carol LehtoPrincipal Data Manager
Carol has more than 20 years of experience in the medical device industry, with 18 of those years spent at NAMSA. Her expertise includes clinical trial administration, monitoring, database Case Report Form (CRF) development, data review, database validation and training in a variety of platforms. Carol has an A.A. from Normandale–Bloomington, MN.
Brenda BebeauSenior Clinical QA Specialist
Brenda has over five years of experience in medical device clinical research. Her current responsibilities include internal clinical audits, external client and regulatory audit support and internal quality management support. Prior to coming to NAMSA, she worked as a Clinical Research Associate, overseeing clinical research operations within a large company and a small start-up company. She holds an M.S. in Applied Clinical Research from St. Cloud State University and a B.A. in Communications and Adult Training and Development from Metropolitan State University.