PPA/Lead CRC
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.

The Analyst II serves as liaison between centralized ITR services and the manager of the Hematology oncology research program to expedite regulatory approvals and study initiations. Responsibilities include working closely with the research manager, 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 regulatory issues; facilitate effective, timely and clear communications within the research program; and establish good relationships with the oncology faculty, the HDFCCC, and other campus departments in order to represent the research program effectively. 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 be responsible for the Lead CRC role for coordinating Research Billing. Must understand budget preparation for clinical trials, interprets and trains the CRC on how to proceed in proper billing of study procedures. Oversees and trains CRCs in timely review of charges. Responsible for working with research manager and division or department managing the funds for the study. Tasks include tracking patient charges and alerting the department on billable triggers to collect money from the sponsor; and will perform other duties as assigned.

*LI-JD1

Required Qualifications
BA/BS with a major in a related field and two years of experience in administrative analysis or operations research; or an equivalent combination of 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; ability to work within a team environment with faculty and staff at all levels; comprehensive knowledge of the regulatory approval process, clinical trial design and clinical study operations; 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 bending, squatting, climbing stairs, reaching up to shoulder height; pushing/pulling over 60 pounds; reaching above shoulder level; sitting, standing, walking, waist twisting, kneeling, crawling; carrying/lifting 21-30 pounds; gripping/grasping, fine/gross finger manipulation; repetitive movements of upper extremities; may be exposed to chemical agents; tuberculosis, blood, body fluids or tissue, and radiological materials; latex, dust, fumes or gases; loud noises; differentiate color; use protective equipment.

Note: Fingerprinting and background check required.

Preferred Qualifications
Master’s degree in Biological sciences or Epidemiology or statistics; UCSF experience; experience using search engines and writing literature reviews; proficiency with bibliography management software such as EndNote, Papyrus or Reference Manager; 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.

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