Clinical Research Regulatory Specialist

2 weeks ago


Salt Lake, Utah, United States University of Utah Full time
Position Overview

The University of Utah is seeking a dedicated Clinical Research Regulatory Specialist to join our esteemed Division of Pediatric Hematology-Oncology, BMT & Immunology. This role is pivotal in supporting clinical trials related to Bone Marrow Transplant and Immunology, as well as various consortium and industry/government-sponsored studies focused on pediatric oncology.

Key Responsibilities

The successful candidate will be responsible for:
  • Developing and coordinating the submission of regulatory documents to ensure adherence to all applicable regulations.
  • Assisting the Principal Investigator and study team in maintaining compliance with University, state, and federal regulations governing clinical research.
  • Preparing and submitting essential documentation to the Institutional Review Board (IRB), including amendments, investigator's brochures, and informed consent forms.
  • Maintaining accurate regulatory files and logs for each assigned trial.
  • Demonstrating initiative and critical thinking skills to enhance regulatory processes.

Work Schedule

This is a full-time position with a standard work schedule of Monday to Friday, 8:00 AM to 5:00 PM, including occasional evenings and weekends as necessary. Shared on-call responsibilities may apply. Opportunities for a hybrid telework arrangement may be available, contingent upon operational needs.

Qualifications

Applicants should possess:
  • A Bachelor's degree in a relevant field, coupled with two years of experience in clinical trials or research.
  • Strong communication skills and the ability to work collaboratively in a team environment.
  • Experience in regulatory processes and familiarity with medical terminology is preferred.

Benefits

The University of Utah offers a comprehensive benefits package, including:
  • Affordable health care coverage.
  • Generous retirement contributions.
  • Paid leave and holidays.
  • Tuition reduction for employees and their families.
  • Employee discounts and professional development opportunities.

Commitment to Diversity

The University of Utah values diversity and encourages individuals from all backgrounds to apply. We are committed to improving access to education and healthcare for historically underrepresented populations.

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