Protocol Project Analyst - Melanoma
University of California San Francisco - San Francisco, CA

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The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC, or Cancer Center) 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) is a program of the Cancer Center created to facilitate translational and clinical research focused on 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. These services consist of several functional areas housed within the ITR Clinical Research Support Office (CRSO), including: protocol development, scientific review, regulatory affairs, research personnel management, clinical research office, budgets and contracts office and consultation in various scientific modalities. Cancer research programs across campus are encouraged to participate in the optional centralized services discussed above.

Job overview
The Analyst III-Protocol Project Analyst (PPA) serves as liaison between centralized ITR services and the director of the Cutaneous Oncology research program to expedite regulatory approvals and study initiations. Responsibilities include working closely with the research director, faculty and staff to assess needs, implement procedures and ensure that timelines are met in order to accomplish research objectives; advise the research program director and/or ITR administrator on all personnel, human resource, resource allocation and regulatory issues; facilitate effective, timely and clear communications within the research program; and establish good relationships with the oncology faculty and their academic departments, the HDFCCC, and other campus departments in order to represent the research program effectively. In addition, the position will coordinate timely completion of regulatory approvals, contract and grant review, and other study start-up procedures to achieve specific timelines for opening investigator-initiated and industry-sponsored studies for the treatment of cancer. The incumbent will also perform other related duties as assigned.

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
• Bachelor’s degree, preferably in the Biological Sciences, and three to four years related experience, or equivalent education and experience.
• Experience preparing submissions for institutional review board and/or scientific review board approval of investigator-initiated new studies and amendments.
• Experience using clinical trials management software such as OnCore or Velos to develop protocol calendars and CRF development in the field of oncology.
• Working knowledge of the regulatory approval process, clinical trial design and clinical study operations.
• Demonstrated ability to work within a team environment with faculty and staff at all levels.
• Proficiency using computers in a Windows environment, including advanced skills in Microsoft Word and Excel.
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
• Advanced understanding of clinical research GCPs and oncology and in-depth knowledge of GCPs and the regulatory processes at UCSF, the NCI, CTEP and the FDA.
• Able to conduct QA on multiple data management systems.
• UCSF experience.
• Master’s degree in Biological Sciences, Epidemiology or Statistics.
• Experience using search engines and writing literature reviews.
• Proficiency with bibliography management software such as EndNote, Papyrus or Reference Manager.

University of California San Francisco - 17 months ago - save job - block
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