Clinical Safety Specialist

Description

WHO WE ARE: 

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