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Protocol Review Monitoring Committee Coordinator

Company: University of California - San Diego Medical Cente
Location: San Diego
Posted on: August 21, 2019

Job Description:

UCSD Layoff from Career Appointment: Apply by 8/13/19 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor. Special Selection Applicants: Apply by 8/22/19. Eligible Special Selection clients should contact their Disability Counselor for assistance. DESCRIPTION =========== The Moores Cancer Center is one of just 49 in the United States to hold a National Cancer Institute (NCI) designation as a Comprehensive Cancer Center. As such, it ranks among the top centers in the nation conducting basic and clinical cancer research, providing advanced patient care and serving the community through outreach and education programs. The Cancer Center's mission is to translate promising scientific discoveries into new and better options for the care of patients with cancer. The Center supports one of the broadest ranges of cancer activities in the nation from fundamental and translational cancer research in molecular genetics and advanced molecular therapeutics, and from population studies of cancer incidence to community education about cancer prevention and risk reduction. The Clinical Trials Office (CTO) at the Moores UCSD Cancer Center administers many clinical trials on behalf of its member investigators, including trials sponsored by National Cancer Institute cooperative groups, pharmaceutical companies, and physician investigators. The Protocol Review & Monitoring Committee (PRMC) Coordinator has a key role in coordinating all administrative aspects of the protocols that will be reviewed for scientific merit by the Protocol Review and Monitoring Committee. Key to this role is the administrative support for the preparation of clinical trial protocols and related regulatory documents for submission to the Protocol Review and Monitoring Committee (PRMC) in order to obtain its approval for the clinical trials to proceed. The PRMC Coordinator will act as a resource to the PRMC Analyst and indirectly to investigators and PRMC Chair for interpretation and execution of complex clinical research regulations, policies & procedures concerning the conduct of clinical trials, including those of the FDA, HHS, NIH, NCI and UCSD IRB. This position is responsible for the tracking and initial administrative review of the PRMC applications submissions. This position requires regular interaction with a variety of internal and external contacts including administrative and research staff from the university that propose a clinical cancer trial. This member will interact indirectly with Cancer Center investigators and staff and UCSD IRB staff The PRMC Coordinator will be responsible to provide the technical and administrative support to the PRMC Analyst preparing meetings, during and after PRMC meetings. This involves writing confirmation letters, requirement letters to the Clinical Investigators, scheduling their presentations, as well as writing approval or approve-pending letters or deferral, as pertinent. There will be the need to track individual projects enrollment and determine whether annual target is met and thus, determine if the study should remain open. There are letters to follow up that are required. MINIMUM QUALIFICATIONS ====================== * Working knowledge of medical and pharmaceutical terminology and concepts, and/or of biological science, sufficient to understand the contents of medical research protocols and research processes. * Experience working with FDA regulations, NCI policies and procedures, and Good Clinical Practice guidelines for the conduct of clinical research. * Experience preparing various forms, documents, and reports, such as Investigational Drug Fact Sheet, New Study Applications, Renewal Applications, IND Applications, etc. Experience preparing, reviewing, and understanding clinical research protocols and protocol amendments. * Understanding scientific oncology terminology and applying this to regulatory submissions for protocol review and scientific committee's requirements. * Administrative experience in summarizing scientific reviews, ability to format and edit minutes for the Protocol Review and Monitoring Committee. * Experience developing and maintaining record management systems. * Excellent interpersonal, as well as written and oral communication skills (using grammatically correct written English and accurate typing) to interact with mid level clinical staff members. * Strong administrative experience using standard word processing and data management software programs, including Word and Excel, in order to develop and prepare reports. * Experience with editing, including summarizing information into concise and condense documents. * Skill in working independently and following through on assignments with minimal supervision. Good judgment to know when to ask for assistance from supervisor in cases where regulations and policies & procedures are unclear. * Experience reading and interpreting clinical trials research protocols. * Demonstrated ability to work with large central databases. PREFERRED QUALIFICATIONS ======================== * Knowledge of technical programs supporting recording, videotaping and remote-meeting access, similar to GotoMeetings. * Experience and ability to accurately collect, record, transcribe and synthesize clinical data. SPECIAL CONDITIONS ================== * Employment is subject to a criminal background check and pre-employment physical. * Must be able to maintain strict confidentiality. * Must be available to work occasional evenings and weekends (will coordinate and attend PRMC meetings twice per month, as needed).

Keywords: University of California - San Diego Medical Cente, San Diego , Protocol Review Monitoring Committee Coordinator, Other , San Diego, California

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