Clinical Research Safety Specialist - Remote

Role Summary

As a Clinical Research Safety Specialist at the Sarah Cannon Research Institute (SCRI), you will support regulatory compliance and patient safety across clinical research studies. This remote role (US) involves preparing and submitting documents to Institutional Review Boards (IRBs), maintaining regulatory files (IND Safety Reports, Investigator Brochures, etc.), ensuring accurate and timely documentation throughout clinical trials, and collaborating with Regulatory Affairs, study teams, and Principal Investigators.

This is a remote position based in the United States. Relocation assistance and visa sponsorship are not available.

• Prepare and submit regulatory documents to IRBs and other oversight bodies.
• Maintain and organize IND Safety Reports, Investigator Brochures, and other regulatory documentation.
• Monitor and support compliance with federal regulations, sponsor requirements, and institutional policies.
• Assist with regulatory submissions and ongoing regulatory affairs activities for industry‑sponsored and investigator‑initiated trials.
• Partner with Regulatory Affairs leadership, study teams, and Principal Investigators to ensure regulatory requirements are met.
• Support audit and inspection readiness by maintaining complete, accurate, and current regulatory files.
• Track deadlines and manage multiple priorities while ensuring timely completion of submissions and compliance‑related activities.
• Perform other duties as assigned.

• Bachelor’s Degree required.
• Minimum 1+ year professional experience in clinical research, biotechnology, life sciences, pharmaceutical, or hospital environment.
• Knowledge of IRB, FDA, and GCP guidelines required.
• Scientific and clinical research terminology knowledge required.
• Proficient with Microsoft Office products (Excel, Word, Outlook).
• Exceptional organizational skills required.

Competitive compensation, including base salary, annual bonus opportunities, and long‑term incentive plans. Total Rewards package includes comprehensive benefits for physical, mental, and financial well‑being.

We are an equal‑opportunity employer and do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.