Oncology Regulatory Affairs Specialist

Sarah Cannon Research Institute; Nashville (TN); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

Benefits package

Job summary

Sarah Cannon Research Institute (SCRI) is hiring a Research Regulatory Affairs Specialist to manage regulatory compliance for industry sponsors and study sites. You will work with regulatory affairs leadership and principal investigators to ensure audit readiness and adherence to SOPs.

The role emphasizes maintaining regulatory documentation, supporting IRB submissions, and processing protocol amendments with timely communication to sponsors and stakeholders. Equal opportunity employer.

Qualifications

• Knowledge of FDA and regulatory processes preferred.
• Experience with regulatory submissions and IRB documentation.
• Familiarity with clinical research operations and site management.

Responsibilities

• Manage regulatory affairs compliance for industry sponsors/sites.
• Collaborate with management, directors, and investigators to ensure compliance.
• Prepare for audits and ensure timely regulatory submissions.
• Maintain regulatory documentation and SOP alignment.
• Support IRB submissions and protocol amendments as needed.

Skills

Regulatory affairs knowledge

FDA regulations

Clinical research experience

Documentation management

IRB processes

Education

Associate's degree or higher

Tools

Documentation systems

Job description

Sarah Cannon Research Institute (SCRI) is hiring a Research Regulatory Affairs Specialist to manage regulatory compliance for industry sponsors and study sites. You will work with regulatory affairs leadership and principal investigators to ensure audit readiness and adherence to SOPs.

The role emphasizes maintaining regulatory documentation, supporting IRB submissions, and processing protocol amendments with timely communication to sponsors and stakeholders. Equal opportunity employer.