Associate Study Director jobs in United States
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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

GLP regulationsLaboratory experienceAnimal Welfare RequirementsData analysisScientific reporting

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

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NAMSA is a medical research organization speeding product development for medical devices, IVDs, regenerative medicine.

Funding

Current Stage
Late Stage
Total Funding
unknown
2020-09-01Acquired

Leadership Team

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Matthew Micowski
SVP & CFO
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Timothy Mitchell
VP - Strategic Partnerships & MRO
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Company data provided by crunchbase