Regulatory Coordinator

Description

This role is responsible for coordinating regulatory activities for clinical research studies across assigned units, departments, or divisions. The incumbent reviews clinical research protocols in detail and prepares, manages, and submits all required regulatory documents and applications to meet UCLA, FDA, sponsor, and other regulatory requirements. The position works closely with study monitors to collect, review, and maintain regulatory documentation, ensuring timely submissions and full compliance with federal, state, and university policies.

Salary: $33.09 - $65.77 hourly

Qualifications

Required:

• Bachelor's degree and/or equivalent combination of education and experience.

• Minimum of 1+ years of experience as a clinical researcher

• 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.

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

• 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.

UCLA Health welcomes all individuals, without regard to race, sex, sexual orientation, gender identity, religion, national origin or disabilities, and we proudly look to each person’s unique achievements and experiences to further set us apart.