Senior Clinical Research Associate

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $68.8k - $133.7k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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

• Work on assigned studies to ensure human subject protection, Good Clinical Practice (GCP), and applicable regulations are followed • Coordinate and manage clinical site monitoring responsibilities in accordance with contractual agreements, SOPs, and regulatory guidelines • 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 about enrollment, conduct, and close-out issues • Communicate site performance, trends, deficiencies, and concerns to site investigators and project teams • Support study start-up activities, including study document tracking and quality review and site activation letters • 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 required documents, perform quality control reviews, and manage renewals • Track 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, including narrative writing and managing the CEC/DSMB • Prepare and coordinate submissions to regulatory authorities OUS • Assess investigative site suitability and provide input to site selection • Assist with site budgets and contract negotiations • Assist sites with audits and resolution of audit action items; support audits remotely and onsite • Participate in meetings with prospective clients • Support training and mentoring of CRAs during remote and onsite visits • Assist the Clinical Study Manager with clinical protocol, investigational plan/brochure, SIV training presentations, and study operations development • Support Core Laboratory management and serve as primary contact when assigned • Support data management, 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 activities as assigned

🎯 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 • Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required • Extensive use of a computer keyboard • Ability to occasionally lift and/or move up to 25 pounds • Ability to meet the stated physical demands, with reasonable accommodations where applicable

🏖️ 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