Regulatory Project Manager - Hematology/Oncology (Fully Remote)

UCLA Health is seeking an experienced Regulatory Project Manager for their Hematology/Oncology division. The role involves regulatory coordination of complex clinical research studies, including the preparation and submission of required regulatory documents in compliance with various regulations.

Responsibilities:

• Responsible for regulatory coordination of complex clinical research studies within assigned units, departments or divisions
• 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
• 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

Requirements:

• 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
• Bachelor's degree