Clinical Safety Specialist
On-siteConcord, North Carolina, United States
Job Summary
Conduct Clinical Safety monitoring activities for BD Peripheral Intervention studies to proactively identify reportable safety events, track trends, and address data queries. Serve as the Clinical Safety expert for stakeholders, investigators, and site personnel by facilitating communication, managing vendor interactions, and leading safety meetings. Develop and maintain study-specific tracking reports, Clinical Safety Plans, and audit-ready Trial Master Files while ensuring compliance with GCP and global procedures. Provide critical thinking support for issue escalation and participate in internal or external audits to resolve findings. Report product complaints and safety events to stakeholders in accordance with established regulations.
Required 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
- Proficiency with Microsoft Suite tools (Outlook, Word, Excel, PowerPoint, OneNote, To-Do, SharePoint, etc.)
- Proficient knowledge of clinical study processes and systems (eTMF, CTMS and CDMS)
- Strong interpersonal and communication/presentation (oral and written) skills
- Strong organizational skills, attention to detail, critical thinking and analytical skills
- Able to manage and delegate multiple tasks and prioritize importance of tasks/projects
- Able to travel up to 10% (or more during peak times)
- Bachelor's Degree (BS/BA) in life sciences, nursing, a related healthcare field equivalent
- 2+ years of experience in clinical research (medical device, pharmaceutical and/or biotechnology)
- 2+ years of experience with clinical safety management or medical device safety reporting
- Minimum of 4 days of in-office presence per week
- Proof that you are fully vaccinated against COVID-19
Desired Qualifications
- Prior experience with clinical studies related to peripheral vascular diseases, end-stage kidney disease and/or oncology
- Experience with medical device studies
- Proficiency with Veeva Vault CTMS, CDMS and eTMF
- Professional certification through one or more relevant associations (e.g., ACRP, SOCRA, etc.)
- MA/MS preferred
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