Clinical Research Execution Services Director

Ucla Health Los Angeles , CA 90009

Posted 2 months ago

The Director of the Clinical Research Execution Services (CRES Director) participates in all research development activities as part of the Jonsson Comprehensive Cancer Center (JCCC), Clinical Research Unit (CRU) under the direction of the Faculty Director, JCCC Director and Division Manager (Senior Leadership). Will oversee research study execution by Clinical Research Coordinators, Data Managers, and Research Assistants, as well as regulatory maintenance and will be responsible for management and oversite of the CRU Hematology-Oncology research teams, both in Santa Monica and Westwood facilities. This includes direct oversight of the Santa Monica Research Operations Manager, Santa Monica Research Scheduler Manager and Santa Monica Research Nurse Manager, and Westwood Translational Team for Hematology-Oncology.

Interface with the Santa Monica clinical locations including Santa Monica Hospital to ensure Hematology-Oncology trials are being conducted according to GCP and UCLA policy. The CRES Director will be responsible for interfacing with study monitors and industry partners to ensure good working relations and overall study conduct is meeting expectations. The CRES Director will coordinate the training of team members participating in research, including clinical staff and faculty as well as research staff and work with Hematology-Oncology faculty conducting clinical research in the CRU to ensure proper conduct and oversight.

The CRES Director will act as a liaison between the CRU and other departments/divisions on campus to ensure proper execution of CRU clinical trials. Work may be assigned by Senior Leadership, 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. Ability to work flexible hours and/or overtime to meet study deadlines and requirements.

Responsibilities

The Director of the Clinical Research Execution Services (CRES Director) participates in all research development activities as part of the Jonsson Comprehensive Cancer Center (JCCC), Clinical Research Unit (CRU) under the direction of the Faculty Director, JCCC Director and Division Manager (Senior Leadership). Will oversee research study execution by Clinical Research Coordinators, Data Managers, and Research Assistants, as well as regulatory maintenance and will be responsible for management and oversite of the CRU Hematology-Oncology research teams, both in Santa Monica and Westwood facilities. This includes direct oversight of the Santa Monica Research Operations Manager, Santa Monica Research Scheduler Manager and Santa Monica Research Nurse Manager, and Westwood Translational Team for Hematology-Oncology.

Interface with the Santa Monica clinical locations including Santa Monica Hospital to ensure Hematology-Oncology trials are being conducted according to GCP and UCLA policy. The CRES Director will be responsible for interfacing with study monitors and industry partners to ensure good working relations and overall study conduct is meeting expectations. The CRES Director will coordinate the training of team members participating in research, including clinical staff and faculty as well as research staff and work with Hematology-Oncology faculty conducting clinical research in the CRU to ensure proper conduct and oversight.

The CRES Director will act as a liaison between the CRU and other departments/divisions on campus to ensure proper execution of CRU clinical trials. Work may be assigned by Senior Leadership, 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. Ability to work flexible hours and/or overtime to meet study deadlines and requirements.

Qualifications

Required: Bachelor degree.

At least 10 years or more years of experience in clinical trials. Experience with coordinating and managing patients on clinical trials. Experience with management of team of staff of more than 10 direct reports and 20 indirect reports 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, OnCore and/or Velos 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.

Preferred: Working knowledge of clinical research management systems. Working knowledge of UCLA IRB systems and processes.

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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Clinical Research Execution Services Director

Ucla Health