NAMSA · 2 hours ago
Field Senior Clinical Research Associate
United States
Full-time
Onsite
Senior Level
5+ years expNAMSA is a pioneering company in the medical device materials industry, focusing on safety and regulatory compliance since 1976. The Field Senior Clinical Research Associate will coordinate and manage clinical site monitoring responsibilities, ensuring adherence to Good Clinical Practice and applicable regulations throughout the study lifecycle.
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 overall 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
Assess the suitability of potential investigative sites through screening interviews, regulatory document review and evaluation of study information and provides input to the site selection process
Assists with the coordination of the site budget and contract negotiations as directed by the project lead(s)
Assists in preparing sites for audits and in resolving audit action items
Supports sites during audits remotely and/or onsite as needed
Participates in meetings with prospective clients
Supports training and mentoring of CRAs during remote and onsite visits
Manages the development and/or maintenance of study monitoring plan, templates, trackers, study tools, and site-specific documents
Assists Clinical Study Manager (CSM) with development of human clinical protocol, investigational plan/brochure, SIV training presentations, and study operations development
Supports Core Laboratory management and may serve as the primary contact
Supports data management in CRF development, validation rules, UAT, review data and identify trends, and other reporting/analysis tasks
Performs and summarizes literature searches
Registers trials on Clinicaltrials.gov
Qualification
Required
Fluency in English and local language, if different, required
Higher education degree or equivalent education, training, and experience
Able to work independently once trained
Good verbal and written communication skills
Strong organizational skills
Basic computer proficiency
Understanding of clinical research processes and regulations
Preferred
5 years clinical trial experience
3 years monitoring experience
1 year device trial experience
Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required
Company
NAMSA
NAMSA is a medical research organization speeding product development for medical devices, IVDs, regenerative medicine.
1001-5000 employees
H1B Sponsorship
NAMSA has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
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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