Tawnya Meier has been in the medical device CRO (Contract Research Organization) industry for 2 years and has focused on medical device safety in pre-market studies in multiple therapeutic areas, especially vascular/endovascular and cardiac.
Prior to joining NAMSA, Tawnya maintained a full-time clinical practice for 12 years in the field of Family Medicine and Urgent Care. She also held multiple family medicine department leadership positions. She was first introduced to research in her roles as Study Coordinator with Covance and Quality Assurance Technician with Protein Design Labs before seeking her medical degree.
Dr. Meier has a medical degree and is board certified through the American Board of Family Medicine. She is licensed to practice medicine in Minnesota and Wisconsin and is a member of the American Academy of Family Practice.
CORE COMPETENCIES
- Supporting, overseeing, and contributing to the Safety Team, including CEC (Clinical Endpoint Committee) and DSMB (Data Safety Monitoring Board) activities, Safety Management Plan development, review of adverse events as medical monitor and review of clinical study data
- Supporting clients in development of clinical, scientific, and/or regulatory strategies and contributing to interactions with global regulatory agencies
- In depth knowledge of global safety reporting requirements
- MDR (Medical Device Regulations) 2017/745/MDCG
- ISO 14155 (2020) – Clinical investigation of medical devices for human subjects
- 21 CFR (Code of Federal Regulations) 11, 50, 54, 56, 812
- Fundamentals of Good Clinical Practice (GCP)
- Certified MedDRA (Medical Dictionary for Regulatory Activities) coder
RECENT PROJECTS
- Medical Monitor and oversight of general trial safety–including safety reporting to National Competent Authorities–for an endovascular balloon device
- Medical Monitor and oversight of general trial safety for multiple projects, including:
- Multiple cardiac ablation and cardiac resynchronization therapy device studies
- Radiation therapy study