1-3 years of experience
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Employment Type:
Full time
Job Category:
Health Care & Medicine
Administrative Specialist
(This job is no longer available)
UCLA Health | Los Angeles, CA
Grad Date

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Job Description

Job Duties
Assist with the coordination of study set-up for all Translational Research in Oncology-United States (TRIO-US) Network (Network) clinical trials. Work with the UCLA Study Teams and Pharmaceutical sponsors in preparing, compiling and shipping required regulatory documents. Respond to and resolve sponsor inquiries-written and verbal, and assist with the review and preparation of Network site study consent forms. Assist in the preparation of Network submissions to IRBs. Assist with tracking, maintaining and up-keep of required regulatory documents. Conduct annual regulatory reviews and updates. Maintain Network database and prepare and maintain Network Study Regulatory Binders. Prepare and assist with Sponsor and internal monitoring visits and reviews of Network Regulatory files for assigned studies. Assist in preparing for internal and external audits. Maintain site lists, phone lists, required regulatory documents for assigned Network sites. Prepare and assist with weekly network mailings and teleconferences. Disseminate necessary study information to Network sites. TRIO-US Network sites are located throughout United States and may include UCLA Satellite Sites and retired International sites.

Job Qualifications
One year experience in clinical research in the subspecialty of Hematology-Oncology preferred; Knowledge and experience in a Network research setting. Research certification preferred. Demonstrated experience with multi-study and multi-site clinical research activities. Demonstrated knowledge and understanding of human research policies, regulations, procedures and standards as according to HIPAA, IRB, FDA, ICH, and GCP guidelines. Demonstrated knowledge of FDA and Sponsor regulatory requirements. Knowledgeable of FDA and QA audit processes. Demonstrated familiarity with the requirements for Network and Sponsor study and regulatory documentation. Required knowledge of Microsoft Word, Excel, PowerPoint, Outlook, Internet Explorer. Demonstrated knowledge of the processes, policies, and procedures of the JCCC Clinical Research Unit and affiliated Networks. Demonstrated knowledge of all components the research process as it pertains to clinical trials and studies, i.e., IRB procedures and processes, data management, patient care management, etc. Demonstrated understanding of confidential information, how it is defined, and demonstrated skill in maintaining confidential status of such information. Ability to handle confidential material with judgement and discretion. Demonstrated knowledge of FDA and Sponsor regulatory requirements. Knowledgeable of Sponsor, QA, and FDA audit processes. Ability to work efficiently and complete tasks with a high degree of accuracy. Ability to effectively oversee and manage a high volume of projects as well as adhere to stringent timelines. Ability to multi-task and effectively prioritize workload to meet demands of the Clinical Research Team, Principal Investigators, Sponsor and FDA. Ability to organize multiple projects for efficiency and cost-effectiveness. Demonstrated organizational skills to efficiently and effectively provide project management, data management and monitoring support for multiple clinical trials and projects, providing accurate information in a timely manner. Analytical skills sufficient to work and solve problems with minimal supervision. Skill in coordinating diverse, complex tasks and information transfer among administrators, staff, and Network physicians and on site investigators. Ability to work flexible hours to accommodate research deadlines. Ability to concentrate and focus in a work environment that contains distracting stimuli and competing deadlines. Ability to be flexible in handling work delegated by more than one individual. Ability to understand that work may be delegated by more than one person, depending on the individual needs of the Network sites 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 priori. Strong interpersonal communication skills to effectively and diplomatically interact with others. Demonstrated interpersonal skills to work with physicians, administrators, work colleagues, representatives from sponsors and other to achieve maximum efficiency in reaching and maintaining workplace goals in a professional manner. Strong written communication skills, ability to compose correspondence and maintain large file system. 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. Typing and computer skill/ability including word-processing, use of spreadsheets, e-mail and data entry into clinical trials and Network database (Mac, PC, Word, Word Perfect, Excel, Microsoft). Computer skills using PC platform computers with proficiency in Power Point, Excel, Word to enter data and generate correspondence accurately. Sufficient computer and computer networking knowledge to problem solve common hardware and software problems for novice users via the telephone.

About UCLA Health

For more than half a century, UCLA Health  has provided the best in healthcare and the latest in medical technology to thepeople of Los Angeles and throughout the world. Today we are one of the most comprehensive and advanced healthcare systems in existence. We are comprised of Ronald Reagan UCLA Medical Center, UCLA Medical Center, Santa Monica, Resnick Neuropsychiatric Hospital at UCLA, Mattel Children’s Hospital UCLA, and the UCLA Medical Group, with offices throughout the region.

Ronald Reagan UCLA Medical Center is consistently ranked by U.S.News & World Report as one of the top five hospitals in the nation and the best medical center in the western United States. The doctors, scientists and caregivers of UCLA are leaders in their fields. Every day, they perform pioneering work across an astounding range of disciplines, from organ transplantation and cardiac surgery to neurosurgery and cancer treatment. Year after year, our people have achieved medical breakthroughs and earned the highest industry honors. And we’re just getting started.

The dedicated professionals of UCLA Health are committed to healing humankind, one patient at a time, by improving health, alleviating suffering, and delivering acts of kindness on a daily basis.