Regulatory Affairs Support Specialist

2 weeks ago

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

Overview:

Established in 1965, University of California, Irvine is a distinguished member of the Association of American Universities, consistently ranked among the top public universities in the nation. Renowned for its academic excellence and groundbreaking research, UCI is home to a vibrant community of over 36,000 students and offers a diverse array of 224 degree programs. Located in a thriving and secure environment, UCI stands as Orange County's second-largest employer, significantly contributing to the local and state economy.

The UCI Center for Clinical Research is dedicated to transforming the clinical trial experience. We collaborate across the UCI network to provide essential support to patients, researchers, and industry partners, ensuring a smooth and efficient process for conducting clinical trials. Our objectives include:

Innovate: Harnessing opportunities through creative ideas and innovative methods to enhance our operations.

Accelerate: Collaborating as a cohesive unit to streamline processes and exceed study activation and enrollment goals.

Grow & Inspire: Setting industry standards for exceptional experiences for our stakeholders and enhancing our reputation as high achievers.

Position Responsibilities:
The Regulatory Affairs Support Specialist will collaborate closely with the Lead Regulatory Coordinator to effectively manage the regulatory components of studies conducted through UCI's Center for Clinical Research. This role offers a hybrid work schedule, requiring attendance at both Irvine and Orange offices as needed.

Qualifications:
Required:

  • Proven ability to prioritize tasks and maintain high productivity and quality under tight deadlines and fluctuating workloads.
  • Fundamental understanding of clinical trials and research methodologies.
  • Proficiency in Microsoft Office Suite for generating reports and documents.
  • Strong analytical and problem-solving skills.
  • Excellent communication abilities, essential for liaising with study stakeholders including sponsors, CROs, and principal investigators.
  • Professional demeanor, representing the study to various stakeholders and maintaining positive relationships.
  • Willingness to travel to different office locations and study sites.
  • Detail-oriented, self-motivated, and adaptable to flexible scheduling.
  • Associate's or Bachelor's degree, or equivalent experience.

Preferred:

  • Certification in Clinical Research preferred, but not mandatory.
  • Experience in clinical research is advantageous, but not essential.

Special Conditions:

  • Ability to work both remotely and on-site at the Irvine and Orange offices.
  • Willingness to pursue certification after 1-2 years of on-the-job training.

Compensation and Benefits:
In addition to a competitive salary range, UCI offers a comprehensive benefits package that may include medical insurance, paid time off, retirement savings plans, and various discounts and perks.

Conditions of Employment:
All applicants who accept an employment offer must comply with specific conditions, including background checks, legal eligibility to work in the United States, and adherence to vaccination policies.

Commitment to Diversity:
The University of California, Irvine is an Equal Opportunity/Affirmative Action Employer. We are dedicated to fostering a diverse workforce and creating an inclusive environment for all employees.

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