What are the responsibilities and job description for the Regulatory Project Manager - Hematology/Oncology (Fully Remote) position at UCLA Health System?
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.
Annual Salary Range: $78,500.00 - $163,600.00. Please note, the department’s
target salary range is $78,500.00 - $121,000.00
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.
Preferred:
Bachelor’s degree $78500-163600 Annually Monday – Friday, 8:00am - 5:00pm (PST)
Salary : $78,500 - $163,600