[Hiring] Regulatory Affairs Coordinator @Sarah Cannon Research Institute

Role Description

As the Regulatory Coordinator, you are responsible for managing and planning regulatory affairs compliance for industry sponsors and/or sites in networks. In this position, you will work closely with the regulatory affairs management, department director, and/or primary investigators to ensure compliance, preparing for auditing activities while meeting strict deadlines.

• Process regulatory document signature requests through an electronic signature platform.
• Track documents pending site regulatory signatures.
• Provide site-level regulatory support to the Clinical Operations’ sites and internal department managers regarding the status of start-up and ongoing regulatory maintenance.
• Establish and maintain a document management system for regulatory paper and electronic files.
• Maintain FDA and GCP required regulatory documentation for individual sites, studies, sponsors, and/or other networks, ensuring compliance with local SOPs for format and content.
• Maintain updated physician credentials for network participants and other critical documentation ensuring compliance.
• Triage site requests for regulatory support and identify the correct pathway for issue resolution.

Qualifications

• An Associate Degree, preferably a Bachelor’s Degree.
• Regulatory experience is preferred.
• Customer service experience is preferred.

Benefits

We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves.

• Competitive compensation package determined by performance, experience, skills, equity, regular job market evaluations, and geographical markets.
• Other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

Company Description

Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development.

• In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country.
• Conducted more than 850 first-in-human clinical trials since its inception.
• Contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade.
• Research network brings together more than 1,300 physicians enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S.