Senior Project Manager, IST Team

Job Description:
Responsibilities The Senior Project Manager of the Investigator Sponsored Trials (IST) Team (SPM) will participate in all research activities as part of the clinical research team of the Department of Medicine, Division of Hematology Oncology, located at UCLA and the Translational Research in Oncology-US (TRIO-US) Network under the direction of the investigators and Senior Management (Faculty Director, Director of Research, Medical Director and Director of Finance and Administration) of the Clinical Research Unit (CRU).
S/he will oversee and ensure timely protocol development and response to proposal requests as well as accurate monitoring of investigator initiated clinical research studies, training of IST monitors, data managers, and project managers.
This includes responsibility for training the IST monitors regarding the monitoring of research patient data and study-related information in both source documents and case report forms (CRF).
In addition, the SPM will assist with maintenance of regulatory files to fulfill research requirements.
Work with study teams and study monitors to verify and monitor data to ensure accurate and complete documentation of study patient care and procedures in a timely manner.
Work flexible hours and/or overtime to meet study deadlines and requirements.
Work may be assigned by the investigators, Director 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 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 the research process as it pertains to clinical trials and studies, i.
, IRB procedures and processes, data management, patient care 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 timely.
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.

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