Remote Position

Regulatory Project Manager, Hematology/Oncology (Fully Remote)

🌍 Remote Β· United States πŸ’Ό Full-time

DescriptionWe are seeking an experienced Regulatory ProjectManager who will be responsible for regulatory coordination of complex clinicalresearch studies within assigned units, departments or divisions.In this role,you will perform detailed reviews of clinical research protocols and utilizethat information to prepare, manage and submit all required study / regulatorydocuments and all required applications and forms related to internal UCLArequirements, FDA requirements, sponsor requirements, etc.Additionally, youwill work with study monitors to process, review and collect the appropriateregulatory documents in a timely manner and in compliance with federal, state,and university mandated laws, regulations and policies.The ideal candidate will have at a minimum, 1years of budget / negotiating experience.Salary offers are determined based on variousfactors including, but not limited to, qualifications, experience, and equity.UCLA Health annual salary range for this position is $78,500.00 - $163,600.00.QualificationsRequired :Minimum of 3years of experience of clinical researchcoordination.Interpersonal skills to effectively communicate information in atimely, professional manner and establish and maintain cooperative andeffective working relationships with students, staff, faculty, externalcollaborators and administration and to work as a member of a team.Ability to set priorities and complete ongoing tasks withcompeting deadlines, with frequent interruptions, to meet the programmatic anddepartment needs, while complying with applicable University policies andfederal and state regulations.Analytical skills to assess clinical research protocols andregulatory requirements, define problems, formulate logical solutions, developalternative 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 andregulatory files effectively as well as independently balance the various tasksto 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 softwaretools, systems, and processes can be adopted quickly and efficiently.Demonstrated knowledge of clinical research concepts, policies andprocedures, and human safety protection regulations and laws.Knowledge of and experienceworking with a variety of local and external IRBs, scientific review and otherresearch committees, national cooperative group sponsors, industry sponsors,federal and foundation funding organizations, etc.. Experience: 3 years required

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