The Regulatory Analyst serves as an (Analyst III) for the Clinical Trials Office (CTO) within the Clinical and Translational Science Center (CTSC) at the UC Davis School of Medicine. This position will report to the Project Manager, Clinical Trials Office, and require frequent interaction with the various research related functional offices and programs such as the IRB and Contracts. A key function of this position is to support the CTO clinical trial portfolio and in particular, the investigator-initiated multicenter clinical trials.--Some years of regulatory filing experience in a health care or academic setting. --Advanced background and knowledge of clinical trial operations, including, but not limited to IRB and FDA requirements.--Possess working knowledge of federal & state regulations, GCP guidelines, HIPAA, institutional policies, and SOPs for conduct of human subjects' research in an academic environment.--Working knowledge of clinical research management.--Possess good presentation skills for education and training programs geared toward university research faculty, research staff, in all research departments, divisions, and for CTSC staff and administrators.--Possess good investigative skills with a high degree of accuracy and attention to detail.--Analytical skills to evaluate information, practices, and procedures, formulate logical and objective conclusions, and make recommendations for effective solutions, strategies, and/or approaches.--Knowledge and experience working with key administrative software and computer systems including Windows or Mac OS, Microsoft Office Suite, web browser applications, e-mail applications, RedCap, and Access databases.PREFERRED--Bachelor's public health or science related field highly preferred (For Analyst IV- required)--Master's degree in Public Health or Health Administration is desirable.--Some experience in quality assurance, data analysis and clinical trials research auditing processes. --Certification by RAC, SoCRA, or ACRP. (For Analyst IV- required) SPECIAL REQUIREMENT--Must be able to work flexible schedule to meet the needs of the department.--MAY BE SUBJECT TO A CRIMINAL BACKGROUND INVESTIGATION, DRUG SCREEN, LIVE SCAN FINGERPRINTING, MEDICAL EVALUATION CLEARANCE, AND FUNCTIONAL CAPACITY ASSESSMENT.
About University of California Davis Medical Center
At the end of 2015, we launched a comprehensive and inclusive process to tap into the broad, diverse knowledge of our entire UC Davis Health community to stimulate new and unique ideas for our next strategic plan.Throughout 2016, hundreds of members of our UC Davis Health family, as well as external friends and partners, took part in conversations and provided valuable input into charting a long-t...erm course for our future that will continue the momentum underway to solidify our position as a top-tier health care organization.With your valuable input and talents, I am excited to launch our six new strategic plan goals. Over the next few years, together we will:Lead Person-Centered Care in the best way, at the best time, in the best place, and with the best teamReimagine Education by cultivating diverse, transdisciplinary, life-long learners who will lead transformation in health care to advance well-being and equity for allAccelerate Innovative Research to improve lives and reduce the burden of disease through the discovery, implementation and dissemination of new knowledgeImprove Population Health through the use of big data and precision healthTransform Our Culture by engaging everyone with compassion and inclusion, by inspiring innovative ideas, and by empowering each otherPromote Sustainability through shared goals, balanced priorities and investments in our workforce and in our communityAt a time when our industry is experiencing some of the most formidable changes ever, these are bold aspirations that will anchor us and provide us with clarity of purpose and a path forward. I am fully confident that we will achieve great success knowing we have a solid plan and areas of focus to guide us.I thank everyone who participated in the planning process for their great input and their dedication to our future success.