Senior Clinical Research Associate

🔥 0 minutes ago

🏄 California, Colorado, +2 more states – Remote

🏄 California – Remote ⛰️ Colorado – Remote 🦌 Connecticut – Remote 🦀 Maryland – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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

• Serve as CRA for assigned complex clinical studies, overseeing site selection, initiation, monitoring, and close-out activities • Participate in site feasibility assessments and site selection processes • Ensure study conduct follows clinical protocols, regulatory requirements, IRB/EC requirements, and company SOPs • Prioritize patient safety and ensure informed consent and study procedures are performed accurately and ethically • Review and report AEs/SAEs and protocol deviations • Maintain complete, accurate, audit-ready regulatory documentation and TMFs according to ALCOA principles • Monitor investigational product and study supply inventory • Identify, communicate, and manage study risks and issues • Author, review, and approve Monitoring Plans, source documents, monitoring tools, and site-facing training materials • Perform SDR/SDV and document monitoring activities through timely trip reports • Provide mentoring, training, and functional oversight of CRAs, including contingent CRAs • Lead or review functional job aids and training materials • Present study updates on site status, risks, and issues to functional and study teams • Maintain accurate study data in Veeva Vault CTMS and CDMS • Collaborate with internal teams and CROs to ensure high-quality study execution and oversight • Build and maintain relationships with investigator sites and internal stakeholders

🎯 Requirements

• Bachelor's degree or higher in a healthcare or science-related field; alternate education levels may be considered based on experience and business need • 3 years of field-based CRA experience in the medical device and/or pharmaceutical industry • Strong understanding of clinical trial operations, monitoring practices, investigational product management, and data management • Thorough knowledge of domestic and international clinical research regulations, including ICH GCP, FDA CFR, ISO, and HIPAA • Excellent written and verbal communication skills, including medical terminology • Strong presentation, organizational, time-management, and prioritization skills • Technical savvy and ability to leverage technology for efficiency and performance • Ability to work independently with minimal supervision in a fast-paced environment • Experience with IVD and/or POC studies preferred • Laboratory experience in molecular biology, microbiology, or blood culture preferred • Proficiency with Veeva Vault CTMS and CDMS preferred

🏖️ Benefits

• Comprehensive Total Rewards program • Reward and recognition opportunities • Competitive compensation and benefits programs • Opportunities to learn, grow and thrive • Face-to-face collaboration supporting learning, progress, and success