Regulatory Coordinator

Responsibilities
Participate in all research activities as part of the clinical
research team located at UCLA/UCLA Santa Monica while under the direction of
the team leader, investigators, MSO, Financial Administrative Officer (FAO),
Medical Director, and Research Director (Senior Management) of the JCCC
CRU. The Regulatory Coordinator is responsible for the regulatory
coordination of clinical research studies as a part of the Central
Administration team. This includes responsibility for preparation,
submission and maintenance of regulatory files to fulfill research
requirements. Work with study monitors to process, review and collect the
appropriate regulatory documents in a timely manner. Ability to work
flexible hours and/or overtime to meet study deadlines and requirements. Work
may be assigned by the team leader or Senior Management, and assignments may be
changed on an as-needed basis in order to ensure that studies and patient care
needs are handled appropriately and in a timely manner.Qualifications
Required:* Demonstrated knowledge of 'good clinical practices' for clinical research as defined by the Code of Federal Regulations (CFR).* Demonstrated organizational skills to efficiently and effectively provide data management/monitoring support for multiple clinical trials and projects, providing accurate information in a timely manner.* Demonstrated understanding of confidential information, how it is defined, and demonstrated skill in maintaining confidential status of such information.* Demonstrated ability to prioritize workload to meet demands of PI's, Sponsor and FDA.* Demonstrated knowledge of all components of the research process as it pertains to clinical trials and studies, i.e., IRB procedures and processes, data management, etc.* Demonstrated interpersonal skills to work with patients, their families/ guardians, physicians, administrators, work colleagues, representatives from sponsors and other to achieve maximum efficiency in reaching and maintaining workplace goals in a professional manner.* Ability to understand work may be delegated by more than one person, depending on the individual needs of the clinical study and to carry out job responsibilities as assigned in a timely manner. * Notify direct supervisor of any conflicts in demand on time or priorities.* Computer skills using PC platform computers with proficiency in Excel and Word to enter data and generate correspondence accurately.* Ability to work at more than one site, travel to participating clinics and attend off-site staff meetings, conferences and investigators meetings.
UCLA is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.

86140047