Regulatory Coordinator - Urology

UCLA Health System

Los Angeles, CA

JOB DETAILS
SALARY
$31.51–$62.64 Per Hour
SKILLS
Administrative Skills, Adobe Product Family, Analysis Skills, Clinical Practices/Protocols, Clinical Research, Code of Federal Regulations, Communication Skills, Corrective Action, Detail Oriented, Document Management, Establish Priorities, FDA (Food and Drug Administration), Federal Laws and Regulations, File Maintenance, Financial Management, Foundation Grants, GCP (Good Clinical Practices), High School Diploma, ICH Regulations, Informed Consent, Interpersonal Skills, Maintain Compliance, Microsoft Excel, Microsoft Product Family, Organizational Skills, Problem Solving Skills, Project/Program Management, Protocol Analysis, Regulations, Regulatory Requirements, Requirements Management, Research Protocols, Safety Process, State Laws and Regulations, Team Player, Time Management, University/School Policies, Urology
LOCATION
Los Angeles, CA
POSTED
30+ days ago

General Information

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Work Location Los Angeles, CA, USA Onsite or Remote Flexible Hybrid Work Schedule Monday-Friday, 8am-5pm hours may vary

Posted Date 02122026

Salary Range 31.51 - 62.64 Hourly

Employment Type 2 - Staff Career Duration Indefinite Job 28687

Primary Duties and Responsibilities

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Under the direct supervision of the Clinical Research Supervisor, the Regulatory Coordinator is responsible for submitting and managing all regulatory documentation for the department of urologys clinical research portfolio according to institutional and federal guidelines. Key duties include:

  • Submitting applications to the FDA IRB DSMB ancillary departments and other applicable review committees, including at start-up for all amendments and at continuing review.
  • Maintaining communication with regulatory bodies.
  • Developing informed consent forms.
  • Maintaining regulatory files in paper and electronic form.

You will perform necessary tasks to manage projects and prioritize work to meet necessary deadlines and will be responsible for planning and organizing necessary tasks to ensure adherence to the study protocol and applicable regulations, such as institutional policy and procedures, FDA Code of Federal Regulations CFR, and ICH Good Clinical Practice GCP.

In this role, you will collaborate with the Principal Investigator, ancillary departments, central research infrastructure teams, sponsors, institutions, and other entities as needed to support the administration of all aspects of studies, including but not limited to compliant conduct, financial management, and adequate personnel support.

Hourly Salary Range 31.51 - 62.64

Please note the departments target salary range is 31.51 - 38.31.

Job Qualifications

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Required:

  1. 1 year of clinical research experience
  2. High School Diploma
  3. Interpersonal skills to effectively communicate information in a timely professional manner and establish and maintain cooperative and effective working relationships with students, staff, faculty, external collaborators, and administration, and to work as a member of a team.

Ability to set priorities and complete ongoing tasks with competing deadlines with frequent interruptions to meet the programmatic and department needs while complying with applicable university policies and federal and state regulations.

Analytical skills to assess clinical research protocols and regulatory requirements, define problems, formulate logical solutions, develop alternative solutions, make recommendations, and initiate corrective actions.

Close attention to detail to ensure accuracy in a fast-paced fluctuating workload environment.

Organization skills to create and maintain administrative and regulatory files effectively, as well as independently balance the various tasks to ensure deadlines are met.

Demonstrated proficiency with Adobe and Microsoft suite software, especially Excel, to perform daily tasks efficiently and accurately.

A learning and professional growth mentality so that new software tools, systems, and processes can be adopted quickly and efficiently.

Working knowledge of clinical research concepts, policies, and procedures, and human safety protection regulations and laws.

Knowledge of and experience working with a variety of local and external IRBs, scientific review, and other research committees, national cooperative group sponsors, industry sponsors, federal, and foundation funding organizations, etc.

Preferred:

Associates or Bachelors Degree

As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct or have filed an appeal of a finding of misconduct with a previous employer.

About the Company

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UCLA Health System