Regulatory Affair Project Manager

Responsibilities

Oversee, manage and participate in startup research activities as
part of the Translational Clinical Research Unit while under the direction of
Financial Administrative Officer (FAO), Faculty Director, Medical Director, and
Research Director (Senior Management) of the JCCC CRU. The Regulatory Project
Manager is responsible for the oversight of regulatory coordination for
clinical research studies. This includes responsibility for regulatory coordination
of clinical research studies, preparation, submission and maintenance of
regulatory files to fulfill research requirements. Coordinating and reporting
on the efforts/timelines of fund management, clinical trials administrative
office and coverage analysis. 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 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:* Minimum of five years clinical research experience, with in-depth knowledge of clinical oncology.* Working knowledge in patient electronic medical system.* Working knowledge in working with Velos or similar system.* Four or more years of experience in regulatory processes in clinical research.* At least a year of experience with UCLA IRB and/or other IRB.* Demonstrated working knowledge of current medical terminology specific to oncology, to accurately read entries in patient charts and record accurately and timely, information into study records and other appropriate research data forms.* Clinical research experience, with in depth knowledge of clinical oncology as it pertains to clinical trials and studies.* Demonstrated knowledge of 'good clinical practices' for clinical research as defined by the 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.* 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.

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