Clinical Safety Coordinator
On-siteConcord, North Carolina, United States
Job Summary
Deliver high-quality, compliant operational support for Clinical Safety management activities across BD Peripheral Intervention clinical studies, including EFS, FIH, IDE, and Post-Market phases. Ensure safety-related activities adhere to global clinical procedures, study protocols, GCP, and applicable regulations while maintaining strong relationships with investigational sites, HCP consultants, and cross-functional teams. Facilitate communication between clinical sites and stakeholders, support Trial Master File maintenance, and perform study-level audits to ensure files remain current and audit-ready. Manage study-specific tracking reports, safety event trending, and vendor interactions for Medical Monitors and committees. Provide regular status updates to partners and proactively identify issues to create mitigation strategies. Participate in safety-related meetings and support internal or external audits, ensuring timely resolution of findings.
Required Qualifications
- Proficiency with Microsoft Suite tools (Outlook, Word, Excel, PowerPoint, OneNote, To-Do, SharePoint, etc.)
- Strong interpersonal and communication/presentation (oral and written) skills
- Strong organizational skills, attention to detail, critical thinking and analytical skills
- Able to lead and delegate multiple tasks and prioritize importance of tasks/projects
- Ability to travel up to 10% (or more during peak times)
- Bachelor's Degree (BS/BA) in life sciences, nursing, a related healthcare field equivalent OR a related certification in cardiology or radiology or equivalent combination of training and experience
- 1+ years of experience in clinical research (medical device, pharmaceutical and/or biotechnology), with clinical safety management, medical device safety reporting, or in a clinical setting
- Minimum of 4 days of in-office presence per week
- Proof that you are fully vaccinated against COVID-19
Desired Qualifications
- Knowledge of domestic and international clinical research regulations and guidelines, Good Clinical Practice (GCP) and current industry practices related to the conduct of clinical studies
- Knowledge of clinical study processes and systems (eTMF, CTMS and CDMS)
- Prior experience with Veeva Vault
- 1+ years of experience with clinical safety management or medical device safety reporting
- Experience with medical device studies
- Professional certification through one or more relevant associations (e.g., ACRP, SOCRA, etc.)
- MA/MS preferred
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