NAMSA · 1 month ago
Clinical Research Associate - NAMSA Future Openings USA
Atlanta - Georgia - USA
Full-time
Hybrid
Entry, Mid Level
$54K/yr - $80K/yrNAMSA is a pioneering company in the medical device materials industry, focusing on safety and regulatory compliance. The Clinical Research Associate will be responsible for coordinating clinical site monitoring and ensuring adherence to Good Clinical Practice and regulatory guidelines.
Medical Device
Responsibilities
Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed
Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines
May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits
Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed
Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns
Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc
Performs study-related training
Manages the development and maintenance of study documents, processes and systems as assigned
Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals
Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance
Attends internal and external meetings as required
Provides all job-related progress reports and visit documentation as required
May support safety activities such as narrative writing, managing the CEC/DSMB, etc
OUS: Prepares and coordinates submissions to regulatory authorities
May perform other activities as assigned
Qualification
Required
Fluency in English and local language, if different, required
Company
NAMSA
NAMSA is a medical research organization speeding product development for medical devices, IVDs, regenerative medicine.
Founded in 1967
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2020-09-01Acquired
Leadership Team
Matthew Micowski
SVP & CFO
Timothy Mitchell
VP - Strategic Partnerships & MRO
Recent News
Medical Device Network
2026-01-11
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