Associate Study Director/Study Director

North American Science Associates, Inc.; Northwood (OH); On-site; USD 60,000 - 85,000; Full time

Job summary

NAMSA seeks an Associate to coordinate GLP/non-GLP preclinical studies and act as a primary client contact. You will help design studies, ensure regulatory compliance, and manage data reporting from initiation to completion.

You will collaborate with cross-functional teams, monitor schedules and budgets, document results, and support training and process improvements in a dynamic lab environment.

Qualifications

• 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.

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.
• Serves as the Study Director for GLP and non-GLP preclinical studies and assures that all applicable GLP regulations are followed.
• Interacts as needed with clients, auditors, inspectors, subcontractors, consultants, and other individuals or departments.
• Develops and leads moderately complex study designs as needed, serves as the primary contact for the client as assigned, and keeps the client informed of schedule and any unforeseen events or issues.
• Establishes and ensures schedule, budget and quality commitments are met for the client.
• Manages internal multidisciplinary team members to ensure that client expectations are met.
• Understands investigational product(s) including high-level understanding of the Medical Device Development Process.
• Evaluates, analyzes, and interprets study data and presents in a clear, well-organized, scientifically sound report.
• Assists with departmental training as needed.

Skills

Lab experience

Scientific writing

Project coordination

GLP knowledge

Education

Bachelor's degree in science

Master's or PhD with 1+ year lab experience

Tools

Fluoroscopy

Faxitron X-ray imaging

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.
• Interacts as needed with clients, auditors, inspectors, subcontractors, consultants, and other individuals or departments.
• Participates in client discussions regarding study design when needed.
• Develops and leads moderately complex study designs as needed, serves as the primary contact for the client as assigned, and keeps the client informed of schedule and any unforeseen events or issues.
• Establishes and ensures schedule, budget and quality commitments are met for the client.
• Manages (motivates, communicates) internal multidisciplinary team members to ensure that client expectations are met.
• Understands investigational product(s) including high-level understanding of the Medical Device Development Process.
• Evaluates, analyzes, and interprets study data and presents in a clear, well-organized, scientifically sound report.
• Assists with departmental training as needed.
• Other duties as assigned.

Qualifications & Technical Competencies:

• 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.

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. NAMSA was founded on the principals of delivering quality customer service, conducting ourselves with integrity, respect for one another, open communication and collaboration. Whether you have a background in Laboratory Science, Clinical Research, Regulatory Affairs, Quality Assurance, Engineering, or Sales & Business, NAMSA offers exciting opportunities to align with your expertise.