Clinical Safety Specialist

Clinical Safety Specialist

If you've owned adverse event processing in a clinical trial…this will feel very familiar.

We're partnering with a structural heart company in Minnesota on a Clinical Safety Specialist role supporting an investigational heart valve program.

This is a fully on-site, execution-heavy role—not a strategy or oversight role. You're in it day-to-day, making sure nothing slips through the cracks.

Your role with the company:

• Processing AEs and SAEs end-to-end

• Reviewing source docs and chasing down missing data

• Writing safety narratives and supporting regulatory reporting

• Keeping everything inspection-ready at all times

• Working closely with Clinical, Regulatory, and Data teams onsite

Desired Profile:

• Required: Bachelor's degree and Engineering or Chemistry preferred
• Understanding of medical and clinical terminology.
• Understanding of HIPAA and patient privacy regulations, including handling of protected health information (PHI).
• Must be a flexible team player to balance independent work with collaborative project execution.
• Strong adherence to study protocol, standard operating procedures (SOPs), FDA regulations, etc.

Strongly preferred:

• Demonstrated attention to detail (e.g., contribution to research publications, experience reviewing complex clinical/research data for accuracy, preparation of regulatory submissions with safety data).
• Strong clinical analysis and writing skills, including interpretation of clinical and safety data.
• Experience preparing clear, accurate and comprehensive medical/clinical documentation.
• Experience with clinical databases (CatchTrial, Medidata, etc.).

• Someone who is detail-obsessed and deadline-driven

• Comfortable in a fast-paced, high-volume environment

This is one of those roles where execution matters more than anything. If you're someone who takes pride in clean data, tight timelines, and doing things right the first time, you'll do well here.