Clinical Research Specialist 2/20/2017
University of California - Los Angeles Medical Centers
Los Angeles, CA
JOB DESCRIPTIONAPPLY Job Title:
Clinical Research Specialist
8am - 5pm
$20.31 / $3533
$40.13 / $6983
Layoff Referral Deadline:
The Clinical Research Specialist (CRS) will work with the Network Clinical Research Team and UCLA study teams that support the JCCC Clinical Research Unit, the Translational Research in Oncology-US Network (TRIO-US), in the set-up and conduct of Network clinical trials. The CRS will assist with the preparation of Network submissions to IRBs and with the review and preparation of Network site study consent forms. The CRS will ensure that all study safety data (i.e. MedWatch's, SAEs, protocol waivers/exceptions, deviations/violations) are processed, recorded and reported properly to the Sponsor and IRB and/or FDA, as appropriate. The CRS will assist with reviewing amendments, supplements, annual reports, controlled documents for FDA submissions and interact with the FDA, as required. The CRS will prepare for and assist with Sponsor and internal/external monitoring visits and reviews for Network Regulatory. The CRS will respond to and resolve sponsor queries-both written and verbal. The CRS will assist in updating the Network database and Network Study Regulatory Binders. The CRS will assist with tracking, maintaining and keeping required regulatory documents current by conducting annual regulatory reviews and updates. The CRS will maintain site and phone lists, required regulatory documents, weekly Network mailings and disseminate necessary study information to Network sites. The CRS will assist with audits/regulatory inspections, participate in study initiation meetings and staff/team meetings, as required. The CRS may also assist with international sites, special projects, which pertain to unique ongoing trials, or perform other duties as specified.
Demonstrated working knowledge of current medical terminology specific to oncology, to accurately read and comprehend patient study information and record accurately and timely, information into study records and other appropriate research data forms. 2 years experience in a Hematology-Oncology Clinical Research Network environment. Demonstrated experience coordinating and overseeing multi-study and multi-site clinical research activities. Demonstrated team leading and/or supervisory skills. Demonstrated knowledge of the processes, policies, and procedures of the JCCC Clinical Research Unit and affiliated Networks. Demonstrated knowledge and understanding of human research policies, regulations, procedures and standards according to IRB, FDA, and GCP guidelines. Demonstrated knowledge of FDA and Sponsor regulatory requirements. Knowledgeable of Sponsor, QA, and FDA audit processes. Demonstrated knowledge of the principles, procedures, and ethical considerations in the conduct of clinical trials in an oncology setting. Demonstrated knowledge of the requirements for Network and Sponsor study and regulatory documentation. Ability to effectively oversee and manage a high volume of projects as well as adhere to stringent timelines. Ability to effectively train and supervise support staff. 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 project management, data management and 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 the Clinical Research Team, Principal Investigators, Sponsor and FDA. 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 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. 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 priorities. Computer skills using PC platform computers with proficiency in Power Point, Excel, Word, Access 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.