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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 play a critical part in ensuring the successful management of regulatory aspects of clinical trials conducted through our Center for Clinical Research.

Key Responsibilities
  • Collaborate with the Lead Regulatory Coordinator to ensure compliance with regulatory requirements and guidelines.
  • Develop and maintain accurate and up-to-date documentation, reports, and records related to clinical trials.
  • Communicate effectively with study stakeholders, including sponsors, CROs, PIs, and departmental units.
  • Provide support for the development and implementation of regulatory strategies and procedures.
  • Participate in training and professional development opportunities to enhance knowledge and skills in regulatory affairs.
Requirements
  • Bachelor's degree in a related field or equivalent experience.
  • Basic understanding of clinical trials and research principles.
  • Excellent communication, problem-solving, and organizational skills.
  • Ability to work in a fast-paced environment with multiple priorities and deadlines.
  • Proficient in Microsoft Office and ability to generate reports and documents.
Preferred Qualifications
  • Certified Clinical Research Professional (CCRP) certification.
  • Experience in clinical research or regulatory affairs.
What We Offer

The University of California, Irvine offers a competitive salary range of $26.6-$43.82 per hour, as well as a comprehensive benefits package, including medical insurance, sick and vacation time, retirement savings plans, and access to discounts and perks.

We are an equal opportunity employer and welcome applications from diverse candidates. If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity.