Note: The job is a remote job and is open to candidates in USA. BD is a global medical technology company focused on advancing healthcare through innovative medical products and solutions. The Clinical Research Associate manages and monitors assigned clinical studies and investigative sites, ensuring compliance with GCP, regulatory requirements, company policies, and quality standards. The role collaborates with cross-functional teams, supports site management and study oversight, and requires approximately 40% travel.
Responsibilities
- Manage and monitor assigned clinical sites and studies to ensure compliance, quality, and operational success
- Conduct monitoring activities, including 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) according to study requirements
- Develop a comprehensive understanding of study protocols, investigational products, instructions for use (IFU), and related study documentation
- Review and contribute to monitoring plans, study source documents, and other study-related materials
- Ensure sites conduct clinical studies in compliance with protocol requirements, GCP, ISO standards, regulatory requirements, and IRB/EC policies
- Prioritize patient safety and verify proper informed consent procedures are followed and documented
- Support site feasibility assessments and site selection activities
- Prepare timely, accurate, and high-quality monitoring reports, visit documentation, and communication records
- Facilitate site initiation visits and support the development and delivery of site-facing training and presentation materials
- Identify, communicate, and help resolve study risks, issues, and compliance concerns
- Participate in study team meetings and provide regular updates regarding site status, performance, risks, and progress
- Maintain Trial Master Files (TMF) and ensure timely site closeout activities
Skills
- 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 applicable regulations and guidelines, including ICH-GCP, FDA regulations, ISO standards, and HIPAA requirements
- 2 years of Clinical Research Associate experience, Clinical Research Coordinator experience, 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 working 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
Benefits
- Remote work arrangement
- Reward and recognition opportunities
- Learning, growth, and development opportunities
Company Overview
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