Study Coordinator jobs in United States
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NAMSA · 13 hours ago

Study Coordinator

NAMSA is a pioneer in the medical device materials industry, focusing on safety and innovative solutions for global healthcare. The Study Coordinator will support Study Directors in preclinical studies by assisting with data collection, study planning, and communication with stakeholders to ensure successful study outcomes.

Medical Device

Responsibilities

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

Qualification

Laboratory experienceScientific discipline degreeData collectionStudy coordinationEffective communication

Required

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

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