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Clinical Trials Regulatory Coordinator – Urology

Ucla Health
UCLA Health
2-3 years
$31.51 – $62.64 per hour
10 Feb. 11, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Trials Regulatory Coordinator – Urology
Location: Los Angeles, California, United States
Work Schedule: Monday–Friday | 8:00 AM – 5:00 PM
Employment Type: Staff – Career (Indefinite Appointment)
Salary Range: $31.51 – $62.64 per hour
Department Target Rate: $31.51 per hour
Job ID: 27620
Industry: Clinical Research | Regulatory Affairs | Urology Clinical Trials | Academic Medical Center


Clinical Trials Regulatory Coordinator – Urology | FDA, IRB & GCP Compliance | Los Angeles, CA

UCLA Health is seeking a detail-oriented and compliance-driven Clinical Trials Regulatory Coordinator to support the Institute of Urologic Oncology’s clinical research portfolio. This career opportunity is ideal for professionals with experience in clinical trial regulatory submissions, FDA documentation, IRB coordination, and ICH-GCP compliance.

Join a leading academic medical center dedicated to advancing research in urologic oncology and improving patient outcomes through innovative clinical trials.


Position Overview

Under the supervision of the Clinical Trials Administrator, the Regulatory Coordinator will oversee the preparation, submission, and maintenance of all regulatory documentation in accordance with institutional policies and federal regulations.

This role ensures strict adherence to FDA Code of Federal Regulations (CFR), Institutional Review Board (IRB) requirements, ICH Good Clinical Practice (GCP), and institutional research compliance standards.


Key Responsibilities

Regulatory Submissions & Compliance

  • Prepare and submit regulatory applications to:

    • Food and Drug Administration (FDA)

    • Institutional Review Board (IRB)

    • ISPRC

    • Data Safety Monitoring Boards (DSMB)

    • Ancillary review committees and institutional departments

  • Manage regulatory submissions at study start-up, during amendments, and for continuing reviews.

  • Maintain active communication with regulatory bodies to ensure timely approvals and compliance.

Documentation & File Management

  • Develop and update informed consent forms in compliance with federal and institutional standards.

  • Maintain complete regulatory files in both paper and electronic formats.

  • Ensure accurate documentation of protocol amendments, safety reports, and study correspondence.

Protocol & Study Oversight

  • Plan and organize regulatory activities to meet study deadlines.

  • Ensure adherence to study protocols and applicable regulatory frameworks.

  • Collaborate with Principal Investigators (PI), sponsors, research infrastructure teams, and ancillary departments to support compliant study conduct.

  • Assist in oversight of compliant financial management and adequate staffing support where applicable.


Required Experience

  • Minimum 2–3 years of experience in clinical trial regulatory affairs or clinical research coordination.

  • Hands-on experience with:

    • FDA submissions

    • IRB applications and continuing reviews

    • Regulatory amendments and compliance tracking

  • Working knowledge of:

    • FDA Code of Federal Regulations (CFR)

    • ICH-GCP guidelines

    • Institutional clinical research compliance policies

  • Experience within an academic medical center or oncology research setting is preferred.

  • Urology or oncology trial experience is highly desirable.


Educational Qualifications

  • Bachelor’s degree in Life Sciences, Public Health, Healthcare Administration, or related field required.

  • Advanced certification in clinical research (e.g., CCRP, CCRC, SOCRA, ACRP) preferred.


Technical & Functional Skills

  • Strong understanding of U.S. clinical trial regulatory processes.

  • Excellent organizational and project management skills.

  • High attention to detail and ability to manage multiple concurrent submissions.

  • Proficiency in regulatory document management systems.

  • Strong written and verbal communication skills.

  • Ability to collaborate effectively with investigators, sponsors, and institutional teams.


Work Environment & Schedule

  • On-site role based in Los Angeles, CA.

  • Monday through Friday, 8:00 AM – 5:00 PM.

  • Indefinite career appointment within an academic research environment.

  • Exposure to high-impact urologic oncology clinical research programs.


Compensation

  • Full hourly range: $31.51 – $62.64.

  • Department target rate: $31.51 per hour.

  • Compensation is commensurate with qualifications and experience.


Career Growth Opportunities

This position provides advancement pathways in:

  • Senior Regulatory Affairs Specialist

  • Clinical Research Manager

  • Regulatory Compliance Manager

  • Oncology Clinical Research Leadership

Professionals in this role gain deep expertise in FDA regulatory submissions, IRB compliance, oncology trials, and academic clinical research governance.


About UCLA Health

UCLA Health is a globally recognized academic medical center known for advancing translational research and delivering patient-centered care. The Institute of Urologic Oncology conducts cutting-edge clinical research aimed at transforming treatment standards in urology and oncology.


Apply via ThePharmaDaily.com

If you have 2–3+ years of regulatory experience in clinical trials with strong knowledge of FDA and IRB processes, this Los Angeles-based opportunity offers a career path in academic oncology research compliance.