Clinical Research Associate II

🔥 13 hours ago

🌵 Arizona, Florida, +1 more states – Remote

🌵 Arizona – Remote 🐊 Florida – Remote 🏰 Missouri – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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BD

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1897

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

💰 $24M Grant on 2020-07

Healthcare • Manufacturing • Healthcare Insurance

BD (Becton, Dickinson and Company) is a global medical technology company dedicated to advancing the world of health. It focuses on developing innovative technologies, services, and solutions to improve safety and efficiency in healthcare. BD offers a wide range of products including medication management solutions, surgical solutions, cervical cancer screening, drug delivery systems, and laboratory services. The company is also involved in infection risk management and provides advanced clinical insights to enhance patient outcomes. With a commitment to global health sustainability and social investing, BD is a leader in healthcare technology and services worldwide.

📋 Description

• Provide site management and monitoring support for BDPI clinical studies • Ensure quality, compliance, scientific integrity and ethical conduct of assigned clinical studies • Conduct on-site or remote clinical site monitoring activities • Evaluate sites for qualification or activation and review informed consent forms and subject data • Issue and address data queries and escalate study non-compliance issues • Verify corrective actions, investigational product accountability and regulatory approvals • Review essential study documents and conduct study training and presentations • Ensure timely reporting of reportable events and adequate study supplies • Serve as a product, procedure and clinical study protocol resource for BD stakeholders and investigators • Develop and maintain relationships as the primary site contact • Facilitate communication among clinical sites, BD stakeholders and cross-functional study teams • Develop and manage study-specific tracking reports • Perform Trial Master File audits and resolve or escalate TMF quality issues • Assist with Clinical Trial Management System management • Prepare and complete clinical study activation, monitoring, training, accountability and other essential documents • Provide input on clinical project management, data management, statistics, safety, product and supplier documents • Identify opportunities to improve clinical study performance and provide cross-functional feedback • Communicate product complaints and other study-impacting events to BD stakeholders • Participate in or lead study, CRA and vendor meetings • Support clinical project management with administrative tasks • Identify issues and create mitigation strategies with Clinical Project Management and leadership • Support internal or external audits and inspections • Support continuous improvement and best-practice initiatives • Mentor Site Management & Monitoring personnel and conduct monitoring evaluations or co-monitoring visits

🎯 Requirements

• Bachelor’s Degree (BS/BA) in life sciences or equivalent combination of training and experience (MA/MS preferred) • 3+ years of experience in clinical research (medical device, pharmaceutical and/or biotechnology) • 2+ years of experience with site management & monitoring or managing clinical projects • Knowledge of domestic and international clinical research regulations and guidelines • Knowledge of Good Clinical Practice (ICH GCP/ISO14155) and current industry practices • Proficiency with Microsoft Suite tools, including Outlook, Word, Excel, PowerPoint, OneNote, To-Do and SharePoint • Strong knowledge of clinical study processes and systems, including eTMF, CTMS and CDMS • Strong interpersonal and communication/presentation skills • Strong organizational, attention to detail, critical thinking and analytical skills • Ability to manage and delegate multiple tasks and prioritize tasks/projects • Ability to travel up to 60% or more during peak times • Role may be hired anywhere in the United States • Must live within 45 minutes of an international airport

🏖️ Benefits

• Remote or field-based workplace arrangement • Opportunities to learn, grow and thrive • Face-to-face collaboration and learning culture • COVID-19 workplace accommodations considered pursuant to applicable law