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Regulatory Affairs Coordinator

2 months ago

Orange, California, United States University Of California Irvine Full time
Job Summary

We are seeking a highly skilled and detail-oriented Assistant Regulatory Affairs Coordinator to join our team at the University of California, Irvine. This role will work closely with the Lead Regulatory Coordinator to ensure the successful management of regulatory aspects of clinical trials conducted through our Center for Clinical Research.

Key Responsibilities
  • Manage regulatory aspects of clinical trials, including ensuring compliance with relevant regulations and guidelines.
  • Collaborate with study stakeholders, including sponsors, CROs, PIs, and departmental units, to ensure seamless trial execution.
  • Develop and maintain accurate and detailed records of regulatory activities and communications.
  • Provide excellent problem-solving skills and quick-thinking capabilities to address complex regulatory issues.
  • Travel to different office locations and study sites as needed.
Requirements
  • Associate's or Bachelor's degree or equivalent experience.
  • Basic understanding of clinical trials and research.
  • Proficient in Microsoft Office, including Word, Excel, and PowerPoint.
  • Excellent communication and problem-solving skills.
  • Ability to work in a fast-paced environment with multiple priorities and deadlines.
Preferred Qualifications
  • CCRP certification or equivalent experience.
  • Clinical research experience.
What We Offer

In addition to a competitive salary range of $26.6-$43.82 per hour, we offer a comprehensive benefits package, including medical insurance, sick and vacation time, retirement savings plans, and access to discounts and perks.

The University of California, Irvine is an Equal Opportunity/Affirmative Action Employer. We are committed to attracting and retaining a diverse workforce and creating a welcoming and inclusive environment for all employees.