Clinical Research Associate

🔥 0 minutes ago

🦀 Maryland – Remote

🦀 Maryland – Remote

💵 $75.8k - $121.3k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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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

• Manage and monitor assigned clinical sites and studies to ensure compliance, quality, and operational success • Conduct qualification, initiation, routine monitoring, and closeout visits through onsite, remote, virtual, or in-house methods • Perform source data review (SDR) and source data verification (SDV) • Develop understanding of study protocols, investigational products, instructions for use, and study documentation • Review and contribute to monitoring plans, source documents, and study materials • Ensure compliance with protocol requirements, GCP, ISO standards, regulatory requirements, and IRB/EC policies • Prioritize patient safety and verify informed consent procedures • Support site feasibility assessments and site selection • Prepare monitoring reports, visit documentation, and communication records • Facilitate site initiation visits and support site-facing training and presentation materials • Identify, communicate, and help resolve study risks, issues, and compliance concerns • Participate in study team meetings and provide updates on site status, performance, risks, and progress • Maintain Trial Master Files and ensure timely site closeout activities • Collaborate with cross-functional teams and study sites in a remote or hybrid environment

🎯 Requirements

• Bachelor's degree or higher in healthcare, life sciences, or related scientific discipline • Working knowledge of clinical trial processes, monitoring activities, data management, and investigational product handling • Knowledge of ICH-GCP, FDA regulations, ISO standards, and HIPAA requirements • 2 years of Clinical Research Associate, Clinical Research Coordinator, or relevant laboratory experience supporting clinical research, diagnostics, biotechnology, medical device, or pharmaceutical studies • Experience supporting diagnostic, in vitro diagnostic (IVD), point-of-care (POC), molecular biology, microbiology, or laboratory-based clinical studies • Laboratory experience in molecular biology, microbiology, or blood culture testing • Experience with electronic data capture (EDC), clinical trial management systems (CTMS), and electronic Trial Master File (eTMF) platforms • Experience with Veeva Vault TMF and/or Veeva CDMS platforms • Strong attention to detail and commitment to quality • Ability to build relationships with investigative sites and internal stakeholders • Excellent organizational and time-management skills • Strong written and verbal communication skills • Adaptability and willingness to learn in a fast-paced clinical research environment • Approximately 40% travel

🏖️ 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