Regulatory Coordinator

Regulatory Coordinator
Company:

Ucla Health


Regulatory Coordinator

Details of the offer

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 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 that 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, Word, FileMaker pro to enter data and generate correspondence accurately. Demonstrated English writing skills to generate original correspondence, including reports, using correct grammar, syntax and punctuation. Demonstrated English verbal skills to obtain and convey accurate information, explaining research protocol to patients and other staff. Ability to work at more than one site, travel to participating clinics and attend off-site staff meetings, conferences and investigators meetings.

Under the direction of the team leader, investigators, Director and Assistant Director of the JCCC CRU, and the MSO II, participate in all research activities as part of the Translational clinical research team located at UCLA/UCLA Santa Monica. The incumbent is responsible for the regulatory coordination of clinical research studies. 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, investigator or Administration, 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.

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.


Source: Jooble_Org


Area:

  • Other Jobs / Other Jobs - Crafts

Requirements

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