Regulatory Coordinator

3 weeks ago

Los Angeles, United States University of California Full time
DescriptionUnder the direction of the Operational Managers, Investigators, Financial Administrative Office, Faculty, Medical and Administrative Directors of the Jonsson Comprehensive Cancer Center (JCCC) Clinical Research Unit (CRU) the Regulatory Coordinator is responsible for preparation, submission and maintenance of regulatory applications to fulfill research requirements for open studies in addition to working with Sponsor monitors to timely process, review and collect regulatory documents maintained in the Investigator Site File. All work should be completed according to good clinical practice (GCP), JCCC CRU standard operating policies (SOP), UCLA Institutional Review Board (IRB) and government regulations.
Work may be assigned by the direct supervisors, investigators or Senior Management. Assignments may be changed on an as-needed basis in order to ensure that study and patient care needs are handled appropriately and efficiently. Availability to work flexible hours to meet study or CRU deadlines and priorities is required.
Salary Range: $24.28 - $48.04 Hourly QualificationsRequired:
* 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 support 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.
* 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. #J-18808-Ljbffr

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