Senior Clinical Research Associate – Field Based

🔥 3 minutes 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 • Coordinate and manage clinical site monitoring responsibilities for assigned studies • 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 regarding enrollment, conduct, and close-out issues • Communicate site performance, trends, deficiencies, and concerns to investigators and project teams • Support study start-up activities, including document tracking, quality review, and site activation letters • Perform study-related training • Manage study documents, processes, systems, monitoring plans, templates, trackers, study tools, and site-specific documents • Ensure quality and completeness of central and site master files • Track study site and overall 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 such as narrative writing and managing the CEC/DSMB • Prepare and coordinate regulatory authority submissions OUS • 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 sites during audits • Participate in meetings with prospective clients • Support training and mentoring of CRAs • Assist the Clinical Study Manager with protocol, investigational plan/brochure, SIV training presentations, and study operations development • Support Core Laboratory management • Support data management through CRF development, validation rules, UAT, data review, trend identification, and reporting/analysis • Perform and summarize literature searches • Register trials on ClinicalTrials.gov

🎯 Requirements

• 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 • Preferred 3 years monitoring experience • Preferred 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 • Up to 80% travel for Field Clinical Research Associates • Ability to talk, hear, stand, walk, sit, use hands to finger, handle, or feel, and reach with hands and arms • Ability to occasionally lift and/or move up to 25 pounds • Close vision, depth perception, and ability to adjust focus • 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 • Equal employment opportunity • Pre-employment background and drug screen processes aligned to local, state and federal laws