Senior Regulatory Affairs Specialist - Institutional Trials Unit
University of California San Francisco - San Francisco, CA

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The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC, or Cancer Center) combines basic science, clinical research, epidemiology/cancer control and patient care from throughout the University of California, San Francisco system. It is an interdisciplinary research center, part of a campus-wide multidisciplinary initiative with a goal of enhancing and integrating cancer related research and clinical care at UCSF. The Cancer Center is part of a network of 40 comprehensive cancer centers throughout the United States supported by the National Cancer Institute (NCI). It is led by a seven-member Directors Group and is comprised of 230 members working at the four major UCSF campus and hospital locations.

The Investigational Trials Resource (ITR) program within the Cancer Center was created to facilitate translational and clinical research and the development and use of new, safer and more efficacious therapies for cancer treatment. The ITR provides centralized services essential to cancer researchers across the spectrum and consists of several functional areas including: scientific review, biostatistics, protocol development, data management, regulatory compliance, contract development, and patient registration.
The Clinical Research Support Office (CRSO) is one aspect of the Cancer Center’s Investigational Trials Resource which assists investigators to conduct cancer-related clinical studies by providing the infrastructure for compliance with federal guidelines. The Protocol Development and Regulatory Unit is comprised of three sub-units: The Sponsored Trials Unit (STU), the Institutional Trials Unit (ITU), and the Cooperative Groups Trials Unit (CGTU).

Job overview
The Senior Regulatory Affairs Specialist is in the Institutional Trials Unit (ITU). The ITU is responsible for protocol development, editing, and submissions to the Protocol Review Committee (PRC), the UCSF Committee on Human Research (CHR), and the Food and Drug Administration (FDA). This position supports Cancer Center Investigators by preparing and submitting Investigational New Drug applications (INDs) and Investigational Device Exemptions (IDE) for investigator-initiated studies and maintaining them throughout their life cycle. In addition to the initial IND/IDE, the incumbent will be responsible for the preparation of annual reports, IND safety reports, protocol and information amendments, and other submissions as applicable, as well as submission of the study to The ITU also provides education for clinical research coordinators, Cancer Center members, and physicians in order to ensure compliance with clinical trial regulations. The incumbent will also perform other related duties

About UCSF
The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences.

Required Qualifications
• BA/BS with a major in a related field and two to three years of Regulatory Affairs experience, primarily with INDs; or an equivalent combination of education and experience;
• Working knowledge of Good Clinical Practices (GCP);
• Expert-level knowledge of Microsoft Word;
• Working knowledge of Good Clinical Practice (GCP);
• Working knowledge of FDA regulations related to clinical trials;
• Excellent organizational skills and ability to multi-task; detail oriented;
• Ability to set priorities, work well under pressure, meet deadlines, and work independently;
• Excellent command of English language and ability to communicate effectively in verbal and written mediums
Physical Demands: requires sitting, standing, walking, squatting, bending, waist twisting, kneeling, crawling, climbing stairs, reaching up to shoulder height, lifting/carrying/pushing/pulling over 60 lbs., fine finger manipulation, gross manipulation, simple/power grasp, repetitive movements of upper extremities; may be exposed to loud noise, dust, fumes or gases, chemicals or toxic substances, latex; ability to differentiate color, operating motor vehicles, use of protective equipment.
Note: Fingerprinting and background check required.

Preferred Qualifications
• Clinical research experience at a large university;
• Experience with electronic document management systems, OnCore®, and iMEDRIS;
• Flexibility to meet changing priorities and deadlines in a perpetual start-up environment; can-do attitude and sense of humor;
• 5-10 years of hands-on experience in Regulatory Affairs, primarily clinical regulatory and IND submissions

University of California San Francisco - 15 months ago - save job - block
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