[Hiring] Clinical Research Safety Specialist @Sarah Cannon Research Institute

Role Description

The Clinical Research Safety Specialist plays a critical role in supporting regulatory compliance and patient safety across clinical research studies. Primary responsibilities include:

• Preparing and submitting documentation to Institutional Review Boards (IRBs).
• Maintaining regulatory files related to IND Safety Reports and Investigator Brochures.
• Ensuring accurate and timely documentation throughout the lifecycle of clinical trials.
• Supporting regulatory affairs activities for both industry-sponsored and investigator-initiated studies.
• Collaborating closely with Regulatory Affairs leadership, study teams, and Principal Investigators.
• Facilitating regulatory processes and maintaining inspection readiness.
• Supporting internal and external audit activities.

This is a remote position based in the US; relocation assistance and visa sponsorship are not available.

Key Responsibilities:

• Prepare and submit regulatory documents to Institutional Review Boards (IRBs) and other applicable oversight bodies.
• Maintain and organize IND Safety Reports, Investigator Brochures, and other essential 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 clinical 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.
• Other duties as assigned.

This role requires exceptional attention to detail, strong organizational skills, and the ability to work effectively in a fast-paced clinical research environment while managing competing priorities and regulatory deadlines.

Qualifications

• Bachelor's Degree required.
• Minimum 1+ years' professional work experience in a clinical research, biotechnology, life sciences, pharmaceutical or hospital environment.
• Work experience should include knowledge of IRB, FDA, and GCP guidelines required.
• Work experience of scientific and clinical research terminology required.
• Above average skills with all MS Office products including Excel, Word, Outlook.
• Exceptional organizational skills required.

Benefits

• Comprehensive benefits to support physical, mental, and financial well-being.
• Competitive compensation package determined by performance, experience, skills, equity, and geographical markets.
• Other compensation, such as an annual bonus or long-term incentive opportunities may be offered.