UCLA Health · 4 hours ago
Regulatory Project Manager (Fully Remote)
Los Angeles, CA
Full-time
Remote
Mid Level
$76K/yr - $159K/yr
3+ years exp
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Responsibilities
Responsible for regulatory coordination of complex clinical research studies within assigned units, departments or divisions
Perform detailed review of clinical research protocols
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.
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
Qualification
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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.
Company
UCLA Health
For more than half a century, UCLA Health has provided the best in healthcare and the latest in medical technology to the people of Los Angeles and throughout the world.
10,001+ employees
Funding
Current Stage
Late StageLeadership Team
Alexis Sexton
Chief Financial Officer, Semel Institute
Andrew Titus
Chief Financial Officer - Department of Family Medicine
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