Associate Study Director

NAMSA; Northwood (OH); On-site; USD 52,000 - 68,000; Full time

Job summary

NAMSA is a leading provider focusing on medical device materials safety and regulatory science. This position supports GLP and non-GLP preclinical studies, coordinating work from start to finish and serving as the main client liaison to keep schedules on track.

The role requires at least a Bachelor's degree in a scientific field and a minimum of 1 year of related lab experience; medical device research or pathology background is preferred.

Qualifications

• Bachelor’s degree with a minimum of 1 year of related laboratory experience.
• Medical device research or pathology experience preferred.

Responsibilities

• Assist in coordinating study conduct tasks from initiation to completion.
• Serve as primary client contact and keep the client informed of schedule and issues.
• Ensure studies comply with ISO, GMP, GLP and NAMSA SOPs.
• Act as Study Director for GLP and non-GLP preclinical studies and ensure GLP regulations are followed.
• Possibly participate in study-specific procedures.
• Evaluate, analyze and interpret data and present clear reports.
• Record and organize all data accurately and archive GLP study records when completed.
• Interact with regulatory bodies (e.g., FDA, NMPA, ANSM) as needed.
• Prepare protocol submissions for IACUC review and respond to comments.

Skills

Study coordination

Attention to detail

Client communication

Education

Bachelor's degree in scientific discipline

Job description

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.

We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry’s premier provider. We provide support for clients during every step of the product development lifecycle and beyond.

Come and work for an organization with the:

Vision

to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the

Mission

to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core

Values

• Act with integrity in everything we do.
• Provide best-in-class customer experiences.
• Develop superior talent and deliver expertise.
• Respond with agility and provide timely results.
• Embrace collaboration, diverse perspectives and ideas.

Job Description

• 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.

Qualifications & Technical Competencies

• Medical device research or pathology experience preferred.
• Requires a minimum of a Bachelor’s degree, preferably in a scientific discipline, with a minimum of 1 year of related laboratory experience.

Working Conditions

• While performing the duties of this job, the Associate is regularly exposed to general office conditions, and will be required to regularly work on personal computers and keyboards. The Associate is frequently exposed to a variety of livestock, domestic and laboratory animals and to fluoroscopy and faxitron x-ray imaging. The Associate is occasionally exposed to sharp objects, radioactive isotopes, gasses such as CO2 and isoflurane, toxic or caustic chemicals, and a Bio-Safety-Level 2 (BSL2) environment. On rare occasions, the Associate may be exposed to zoonotic diseases and blood borne pathogens.
• The noise level in the work environment is usually moderate.
• While performing the duties of this job, the Associate is regularly required to sit, stand, walk, use hands and fingers, reach with hands and arms, talk and hear, use computer keyboard, and view computer monitors. The Associate must occasionally lift and/or move up to 50 pounds.
• Specific vision abilities required by this job include close vision, the ability to adjust focus, exceptional spatial acuity and visual-kinesthetic coordination.

NAMSA Is An Equal Employment Opportunity Company.

NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.