Associate Study Director
Job Description
Affords assistance in coordinating study conduct tasks from initiation to completion. Handles non-complex studies and acts as the primary client contact, keeping them updated on schedules and unforeseen events or issues. Ensures compliance with applicable quality system regulations (ISO, GMP, GLP) and NAMSA Standard Operating Procedures (SOPs). Understands and complies with animal welfare requirements and serves as the Principal Investigator when necessary. Acts as the Study Director for both GLP and non-GLP preclinical studies, ensuring adherence to GLP regulations. Participates in study-specific procedures. Analyzes and interprets data, presenting clear, well-organized reports. Guarantees accurate recording, verification, and organization of data, including unanticipated responses. May archive study records for GLP studies upon completion. Interacts with regulatory bodies (FDA, NMPA, ANSM, etc.) for protocol submissions and responses to IACUC reviews. Performs other duties as directed.
Qualifications & Technical Competencies
Medical device research or pathology experience preferred.
Minimum of a Bachelor’s degree, preferably in a scientific discipline, with at least 1 year of related laboratory experience.
Working Conditions
Exposure to general office conditions, computers, and personal keyboards.
Exposure to livestock, domestic and laboratory animals, fluoroscopy, x-ray imaging, sharp objects, radioactive isotopes, gases like CO2, toxic or caustic chemicals, BSL2 environments, zoonotic diseases, and blood borne pathogens.
Regular sitting, standing, walking, hand and finger use, reaching, talking, hearing, using a computer keyboard, viewing computer monitors, lifting up to 50 pounds, occasional bending, stooping, crouching, crawling, and kneeling.
About the Role
NAMSA is a pioneer in the medical device materials industry, having been the first independent company to focus solely on these materials for safety. Founded in 1976, NAMSA has been instrumental in developing the test methods that govern the industry and has become the leading provider of support throughout the product development lifecycle.
Benefits
NAMSA offers a supportive work environment guided by a vision to inspire innovative MedTech solutions, improve patient lives, and drive client success. Our mission is to deliver top-tier MedTech development solutions through our people, expertise, and technology, while adhering to our core values of integrity, excellent customer service, talent development, timely results, and collaborative thinking.
Pay
NAMSA does not specify pay details but offers competitive compensation based on experience and qualifications.
Schedule
NAMSA does not specify the schedule but offers flexible working hours to accommodate different lifestyles.
Skills
The ideal candidate should possess medical device research or pathology experience, along with a Bachelor’s degree in a scientific discipline and at least 1 year of related laboratory experience.
Company Information
NAMSA is committed to equal employment opportunities and participates in pre-employment background and drug screen processes aligned with local, state, and federal laws.