Regulatory Affairs Professional

7 days ago

The Woodlands, United States Lifelancer Full time

We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team at Sarah Cannon Research Institute (SCRI), a leading oncology research organization. In this role, you will play a crucial part in ensuring regulatory compliance for industry sponsors and/or sites in networks.

About the Role

As a Regulatory Affairs Specialist, your primary responsibilities will include managing and planning regulatory affairs compliance, maintaining document management systems, and ensuring Food and Drug Administration (FDA) and Good Clinical Practice (GCP) required regulatory documentation is compliant with local Standard Operating Procedures (SOPs).

  • You will establish and maintain a document management system for regulatory paper and electronic files
  • You will maintain updated physician credentials for network participants and other critical documentation ensuring compliance
  • You will modify and/or develop informed consent forms and update and manage protocol and consent form modifications or amendments in compliance with Institutional Review Board (IRB) policy and HIPAA
  • You will organize and coordinate IRB documentation for trials
  • You will provide initial review and triage of Investigational New Drug (IND) Safety Reports as delegated by the Principal Investigator, and perform subsequent processing of those Safety Notifications that meet the IRB reportable criteria

In addition to these key responsibilities, you will also assist internal or external audit teams with any regulatory-related issues, apprise the Regulatory Affairs Manager and Network Management of all study and site-specific regulatory issues, and archive study specific regulatory documentation and correspondence.

What We Offer

We offer a competitive compensation package, including an estimated salary range of $85,000 - $110,000 per year, depending on experience and qualifications. Our Total Rewards program includes comprehensive benefits to support physical, mental, and financial well-being, as well as opportunities for professional growth and development.

Requirements

To be successful in this role, you should have a Bachelor's degree and two years of experience in healthcare, research, or a related field. You should also possess knowledge of scientific and clinical research terminology, IRB, FDA, and GCP guidelines, and have direct regulatory affairs experience.

About Us

Sarah Cannon Research Institute (SCRI) is one of the world's leading oncology research organizations, conducting community-based clinical trials and advancing therapies for patients over three decades. Our research network brings together more than 1,300 physicians who are actively enrolling patients into clinical trials at over 250 locations in 24 states across the U.S. Learn more about our research offerings here.

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