Clinical Safety Specialist

4 C Medical Technologies • Maple Grove, MN

3h • Onsite

About The Position

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.

Requirements

• 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)

Nice To Haves

• 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

Responsibilities

• 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
• 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
• 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
• 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

Benefits

• Medical
• Dental
• Vision
• Flexible Spending Account (FSA)
• Basic Life
• 401(k) Retirement Plan
• Paid Holidays
• PTO
• Maternity/Paternity paid leave

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees