Regulatory Affairs Specialist - Remote

Overview

As a Regulatory Affairs Specialist at Sarah Cannon Research Institute, you will play a vital role in ensuring compliance with regulatory standards in the oncology research field, contributing to the advancement of cancer treatments.

In Short

• Manage and plan regulatory affairs compliance for industry sponsors and sites.
• Work closely with regulatory affairs management and primary investigators.
• Establish and maintain a document management system for regulatory files.
• Ensure compliance with FDA and GCP documentation requirements.
• Modify and develop informed consent forms in compliance with IRB policy.
• Organize IRB documentation for clinical trials.
• Assist with internal and external audit teams on regulatory issues.
• Maintain updated physician credentials for network participants.
• Archive study-specific regulatory documentation and correspondence.
• Provide initial review and triage of IND Safety Reports.

Requirements

• Bachelor's Degree required.
• Knowledge of scientific and clinical research terminology.
• Understanding of IRB, FDA, and GCP guidelines.
• Two years of experience in healthcare or research.
• Direct regulatory affairs experience preferred.
• Safety experience in clinical research or healthcare environment.

Benefits

• Comprehensive benefits package to support well-being.
• Competitive compensation package based on performance and experience.
• Opportunities for professional growth and development.
• Inclusive work environment with strong values.
• Annual bonus and long-term incentive opportunities may be offered.