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Regulatory Affairs Specialist

2 months ago

Irvine, California, United States University Of California Irvine Full time
About the Role

The University of California, Irvine is seeking a highly skilled Regulatory Affairs Coordinator to join our team. As a key member of our Center for Clinical Research, you will play a critical role in ensuring the successful management of regulatory aspects of clinical studies.

Key Responsibilities
  • Manage regulatory documents, including IRB applications and study protocols
  • Collaborate with study sponsors and monitors to ensure compliance with regulatory requirements
  • Develop and maintain knowledge of regulatory guidelines and best practices
  • Provide support for clinical trials, including IND submissions and FDA inspections
  • Work closely with the research team to ensure seamless study activation and enrollment
Requirements
  • 2-3 years of experience in regulatory aspects of clinical research
  • Excellent communication and problem-solving skills
  • Ability to work independently and as part of a team
  • Basic knowledge of Microsoft Office and clinical trial management systems
Preferred Qualifications
  • Experience with CTMS, preferably OnCore
  • Familiarity with FDA inspection processes
  • CCRP certification or willingness to become certified
What We Offer

The University of California, Irvine offers a competitive salary range of $32.12-$52.92 per hour, as well as a comprehensive benefits package, including medical insurance, sick and vacation time, and retirement savings plans.

Conditions of Employment

The University of California, Irvine is an equal opportunity employer and is committed to diversity and inclusion. We are committed to attracting and retaining a diverse workforce and strive to create a welcoming and inclusive environment for all employees.