Description
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. UCLA
Health salary range for this position is $71,500.00 - $154,900.00/annual.
Qualifications
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.
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University of California - Los Angeles Health
June 14, 2024