Senior Clinical Research Associate (CRA) - Medical Devices
Overview
As a Senior Clinical Research Associate, you own site monitoring and relationship management for complex clinical studies in the medical device and pharmaceutical space. You drive high-quality study execution, ensure compliance with ICH GCP, FDA CFR, and ISO standards, and mentor junior CRAs. You work within a global team at BD (now part of Waters Corporation), collaborating with cross-functional teams and CROs. This role combines rigorous oversight with strategic problem-solving, directly influencing patient safety and trial integrity.
What You'll Do8
- 1Serve as CRA for complex clinical studies, overseeing site selection, initiation, monitoring, and close-out activities both on-site and remotely.
- 2Ensure study conduct adheres to GCP, FDA, ISO, and IRB requirements, prioritizing patient safety and accurate informed consent.
- 3Review and report AEs/SAEs and protocol deviations, maintaining audit-ready documentation in TMFs per ALCOA principles.
- 4Monitor site inventory of investigational products and study supplies, proactively identifying and communicating risks to maintain compliance.
- 5Author and approve Monitoring Plans and source documents, performing SDR/SDV and documenting findings in high-quality trip reports.
- 6Mentor and provide functional oversight to less experienced CRAs, leading training materials and presenting updates to study teams.
- 7Utilize Veeva Vault CTMS and CDMS to maintain accurate study data and collaborate effectively with internal teams and CROs.
- 8Build and maintain strong relationships with investigator sites, ensuring operational continuity and successful study delivery.
Requirements7
- 13+ years of field-based CRA experience in the medical device or pharmaceutical industry.
- 2Bachelor's degree or higher in a healthcare or science-related field.
- 3Strong understanding of clinical trial operations, monitoring practices, and investigational product management.
- 4Thorough knowledge of ICH GCP, FDA CFR, ISO, and HIPAA regulations.
- 5Proficiency with Veeva Vault CTMS and CDMS is preferred.
- 6Experience with IVD and/or POC studies is preferred.
- 7Laboratory experience in molecular biology, microbiology, or blood culture is preferred.
Salary Insight
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