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Clinical Safety Specialist
4C Medical Technologies Inc
- Osseo, Minnesota, United States
- Osseo, Minnesota, United States
Über
If you're energized by collaboration, driven by purpose, and ready to take ownership of your impact, 4C Medical offers more than just a job-we offer the opportunity to help shape the future of medical innovation. As a growing medical device startup, every team member plays a critical role in advancing technologies that improve patient lives. At 4C Medical, you'll find an environment where your ideas matter, your growth is prioritized, and your contributions directly influence our success. We're committed to fostering both personal and professional development in a culture built on accountability, curiosity, and shared purpose. THE OPPORTUNITY We are looking for a motivated Clinical Safety Specialist who is a hands-on, responsible for the day-to-day execution of safety activities for our investigational heart valve. This position ensures adverse events are accurately processed, documented, and reported in compliance with regulatory requirements. Working on-site alongside Clinical, Regulatory, and Data teams, this role plays a critical part in maintaining real-time visibility into patient safety and ensuring inspection readiness throughout the clinical trial. HOW YOU WILL CONTIRBUTE Adverse Event Case Processing
Review, assess, and process adverse events (AEs) and serious adverse events (SAEs) from clinical studies
Thorough review source documents and identifying missing information Ensure completeness and accuracy of clinical study data, Data entry into the clinical trial database in a timely manner Follow up with site managers and internal teams to resolve data gaps quickly
Safety Reporting & Documentation
Prepare safety narratives and support submission of regulatory reports within required timelines
Prepare documentation binders for safety meetings Taking and distributing meeting minutes
Preparing and distributing site follow up letters Maintain accurate, organized, and inspection-ready safety documentation
Track case status and reporting timelines to ensure compliance
Compliance & Quality
Adhere to company SOPs, ICH-GCP guidelines, and FDA regulations
Support internal audits and regulatory inspections
Identify and escalate data quality issues or compliance risks in real time
Onsite Collaboration & Communication
Partner closely with Clinical Operations, Data Management, and Regulatory teams in a highly collaborative, onsite environment
Communicate proactively on case status, issues, and timelines
Support training of internal teams and clinical sites on safety reporting expectations
Schedule safety meetings and maintain calendar and checklist of timelines WHY JOIN US We recognize that meaningful work is supported by meaningful benefits. That's why we offer a competitive compensation package along with comprehensive benefits designed to support you and your family's health, well-being, and financial future.Our benefits package includes:
Medical Dental Vision Flexible Spending Account (FSA) Basic Life
401(k) Retirement Plan Paid Holidays PTO Maternity/Paternity paid leave It is 4C Medical's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state or local laws.
Requirements WHAT YOU NEED TO SUCCEED (Minimum Qualifications)
Bachelor's degree in Nursing (RN), Life Sciences, Pharmacy, or related field
3-5 years of experience in clinical research, pharmacovigilance, or healthcare safety/quality
Working knowledge of ICH-GCP and clinical trial safety reporting requirements
Experience with clinical trial databases (CatchTrial, Medidata, etc.) Proficiency in Microsoft Office (Word, Excel, PowerPoint, etc) WHAT WILL SET YOU APART (Competencies)
Execution-focused: You reliably move cases from intake to submission without dropping details
Attention to detail: You catch inconsistencies before they become compliance issues
Time management: You handle multiple cases and deadlines without losing control
Clear communication: You escalate issues quickly and effectively
Collaborative mindset: You work well in a highly interactive, onsite team environment
Salary Description $88,000 to $105,000
Sprachkenntnisse
- English
Hinweis für Nutzer
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