NAMSA · 2 days ago
Associate Study Director
NAMSA is a pioneering company in the medical device materials industry, focusing on safety and compliance since 1976. The Associate Study Director will assist in coordinating study conduct tasks and serve as the primary contact for clients while ensuring compliance with applicable regulations and quality systems.
Medical Device
Responsibilities
Assists in the coordination of study conduct tasks from study initiation to study completion
Performs noncomplex studies and serves as the primary contact for the client, as assigned, and keeps the client informed of schedule and any unforeseen events or issues
Performs project in compliance with applicable quality system regulations (i.e. ISO, GMP, GLP) and NAMSA SOPs
Knows and understands the Animal Welfare Requirements and serves as Principal Investigator, when applicable
Serves as the Study Director for GLP and non-GLP preclinical studies and assures that all applicable GLP regulations are followed
May need to participate in study specific procedures
Evaluates, analyzes and interprets data and presents in a clear, well-organized, scientifically sound report
Assures that all data including unanticipated responses are accurately recorded, verified and organized
May need to ensure that study records for GLP studies are archived upon completion of the study
May need to interact with regulatory bodies (i.e. FDA, NMPA, ANSM, etc)
Prepares protocol submissions for IACUC review and responds to committee comments/questions as necessary
Other duties as assigned
Qualification
Required
Requires a minimum of a Bachelor's degree, preferably in a scientific discipline, with a minimum of two years' related laboratory experience
Master's degree/PhD with a minimum of one year of relevant laboratory experience
Company
NAMSA
NAMSA is a medical research organization speeding product development for medical devices, IVDs, regenerative medicine.
Funding
Current Stage
Late StageTotal Funding
unknown2020-09-01Acquired
Recent News
Medical Device Network
2026-01-11
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