Regulatory Project Manager (Fully Remote)

We
are seeking an experienced Regulatory
Project Manager who will be responsible for
regulatory coordination of complex clinical research studies within assigned
units, departments or divisions. In this role, you will perform detailed review
of clinical research protocols and utilize that information to prepare, manage
and submit all required study/regulatory documents and all required
applications and forms related to internal UCLA requirements, FDA requirements,
sponsor requirements, etc. Additionally, you will work with study monitors to
process, review and collect the appropriate regulatory documents in a timely
manner and in compliance with federal, state, and university mandated laws,
regulations and policies.

Salary
offers are determined based on various factors including, but not limited to,
qualifications, experience, and equity. UCLA Health annual salary range for
this position is $76,200.00 - $158,800.00.

Required:

• Minimum of 3+ years of experience of clinical research
  coordination
• 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.
• Demonstrated 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.