Senior Clinical Research Associate

🔥 14 hours ago

🇺🇸 United States – Remote

💵 $68.8k - $133.7k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

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NAMSA

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1967

🏥 Healthcare

🏭 Manufacturing

📦 Logistics

Healthcare • Manufacturing • Logistics

NAMSA is a global leader in medical device testing and research, offering comprehensive consulting, preclinical research, clinical research, and testing services for medical device and IVD manufacturers worldwide. With a team of over 1,400 specialists and state-of-the-art labs across North America, Europe, and Asia, NAMSA conducts extensive testing to ensure the safety, efficacy, and compliance of medical devices. The company provides strategic consulting on regulatory submissions and market strategies, helping clients navigate complex regulatory landscapes efficiently and effectively. Founded in 1967, NAMSA is trusted by manufacturers to deliver high-quality services from concept to commercialization.

📋 Description

• Ensure human subject protection, Good Clinical Practice (GCP), and applicable regulations are followed on assigned studies • Coordinate and manage clinical site monitoring responsibilities • Conduct on-site and remote site qualification, site initiation, interim, and close-out monitoring visits • Serve as primary point of contact for site questions and liaise with study team members • Communicate site performance, trends, deficiencies, and concerns to investigators and project teams • Support study start-up activities, including study document tracking and quality review • Perform study-related training • Manage study documents, processes, systems, monitoring plans, templates, trackers, tools, and site-specific documents • Ensure quality and completeness of central and site master files; track documents and manage renewals • Track site and study metrics, including enrollment, deviations, adverse events, and trial master file maintenance • Attend internal and external meetings and provide progress reports and visit documentation • Support safety activities, including narrative writing and management of CEC/DSMB • Prepare and coordinate submissions to regulatory authorities for OUS studies • Assess potential investigative sites and provide input to site selection • Assist with site budgets and contract negotiations • Prepare sites for audits, resolve audit action items, and support audits remotely or onsite • Participate in prospective client meetings • Support training and mentoring of CRAs during remote and onsite visits • Assist the Clinical Study Manager with clinical protocols, investigational plans/brochures, SIV training presentations, and study operations development • Support Core Laboratory management and data management activities, including CRF development, validation rules, UAT, data review, trend identification, and reporting/analysis • Perform and summarize literature searches • Register trials on ClinicalTrials.gov • Perform other assigned activities

🎯 Requirements

• Fluency in English and local language, if different, required • Higher education degree or equivalent education, training, and experience • Preferred 5 years clinical trial experience • Preferred 3 years monitoring experience • Preferred 1 year device trial 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 • SoCRA or ACRP certification preferred but not required • Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates • Ability to meet the stated physical demands, including occasional lifting/moving up to 25 pounds • Extensive use of a computer keyboard

🏖️ Benefits

• Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job