Clinical Safety Specialist

Custom Search Inc.; Maple Grove (MN); On-site; USD 85,000 - 120,000; Full time

Job summary

Custom Search Inc. in Minnesota is seeking a Clinical Safety Specialist to support an investigational heart valve program. This is an execution-heavy on-site role, not strategy, and you’ll be hands-on day-to-day to ensure safety data stays clean and compliant.

You’ll process adverse events (AEs and SAEs) end-to-end, review source docs, write safety narratives, and help with regulatory reporting and inspection readiness. Collaboration with Clinical, Regulatory, and Data teams onsite is constant.

Qualifications

• Bachelor’s degree and Engineering or Chemistry preferred.
• Understanding of medical and clinical terminology.
• Understanding of HIPAA and patient privacy regulations.
• Must be a flexible team player to balance independent work with collaborative project execution.
• Strong adherence to study protocol, SOPs, FDA regulations.

Responsibilities

• 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.

Education

Bachelor’s degree, Engineering or Chemistry preferred

Job description

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.