Study Coordinator at NAMSA in Northwood, Ohio

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:

• Knows and understands the Animal Welfare Requirements and serves as a support to the Study Directors and/Principal Investigator, when applicable.
• Assists Study Directors on select projects under the direction and review of the Study Director team.
• Assists in collection, documentation and analysis of pre-clinical data.
• Assists in the coordination of study tasks from pre-study initiation to study completion.
• Performs accurate and timely record keeping consistent with the maintenance of facility SOPs. Utilizes computer systems to enter and reference data as needed.
• Assists in study planning and design of studies, under the direction and review of the study director team, to meet desired project endpoints, including coordinating pre-study meetings and data review.
• Responsible for study planning activities, assists with generating study protocols when directed, coordinates and monitors activities in support of study conduct.
• Communicates effectively with Sponsors, Study Directors, Principal Investigators and Testing Facility Management on the progress of all studies.
• Assists with data collection, database entry and generating/tabulating data.
• Distributes study related documents, i.e. copies of study data sheets
• Creates documentation per SOP to assist with test/control article accountability.
• May ship specimens, documents, CDs, DVDs etc. per SOP, maintaining accurate chain of custody documentation.
• Assists with generating technical reports as directed and assist in identifying issues and recommend solutions.
• Maintains client inventory and is required to be familiar with internal and competitor products.
• Types correspondence and various types of documentation in proper format and proofreads/distributes as assigned.
• Completes special department projects and duties (i.e., data collection, report creation, information maintenance, contacting personnel for routine updates, etc.) as required to support daily business operations.
• Serves as the Study Coordinator for GLP and non-GLP preclinical studies and supports the Study Director for non-clinical projects.
• Assists Study Directors prior, during and post-study by coordinating scientific, administrative, and logistic support for studies.
• Creates and manages the use and distribution of study related documents, i.e. copies of study data sheets, IACUC information sheets, and study progress tracking documentation.
• Supports semi-moderately complex studies and supports the Study Director keeping the team informed of scheduling needs and any unforeseen events or issues.
• Other duties as assigned.

Qualifications & Technical Competencies:

• Requires a Bachelor's degree (BS/BA) or equivalent in a scientific discipline and 0 - 2 years of related laboratory experience

- OR -

• At least 5 years of laboratory experience without a Bachelor's degree

• Equivalent combination of education and experience may be accepted as satisfactory substitute for the specific education and experience listed above.

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.