Note: The job is a remote job and is open to candidates in USA. Sarah Cannon Research Institute (SCRI) is a leading oncology research organization focused on advancing therapies for cancer patients. The Clinical Research Safety Specialist plays a critical role in supporting regulatory compliance and patient safety across clinical research studies, including preparing documentation for Institutional Review Boards and ensuring compliance with regulations.
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
Skills
- 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
- Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being.
- Competitive compensation package.
- Annual bonus
- Long-term incentive opportunities
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