The Research Compliance Supervisor 2 provides leadership in regulatory affairs for a department-wide clinical research program, processing 150-175 protocols per year with over 260 amendments and modifications. This position also includes supervision and training of lower-level regulatory coordinators and/or other support personnel.REQUIRED-Advanced-level knowledge and understanding of oncology and disease processes as applied to clinical research.-Advanced knowledge of clinical research trials regulations. (i.e., Office of Research and Human Protections (OHRP) and Food and Drug Administration (FDA) is essential.-Advanced knowledge of clinical research regulatory processes and policies.-Administrative skills and ability to independently exercise good judgment, initiative and resourcefulness.-Analytical skills to evaluate information, practices and procedures, formulate logical and objective conclusions and make recommendations for effective solutions.-Ability to supervise and train support staff and to use good judgment based on the knowledge and level of the staff within the unit. Ability to take disciplinary action when necessary.-Ability to analyze and interpret federal, local, and institutional regulatory changes and decide how they will impact internal processes.-Demonstrate oral communication and interpersonal skills to effectively correspond with the general public, co-workers, physicians, patients, caregivers, clinic staff and other health care professionals.-Display organizational skills and attention to detail so that large volumes of records can be accurately maintained to accomplish a task or goal.-Advanced-level knowledge of medical terminology and basic anatomy.-Display writing skills including ability to compose reports and correspondence while utilizing correct grammar, spelling and punctuation as well as clearly documenting research data onto forms.-Ability to meet the scope of the program with minimal supervision and with frequent changes in priorities and deadlines.-Organizational skills to follow through on assigned tasks and adherence to deadlines in a timely manner.-Working knowledge of Microsoft Word, Excel and Access.-Ability to work independently AND/OR cooperatively as a team member in a diverse workforce.-Ability to perform and follow up with multiple projects independently.SPECIAL REQUIREMENT - THIS POSITION MAY BE SUBJECT TO A CRIMINAL BACKGROUND INVESTIGATION, DRUG SCREEN, LIVE SCAN FINGERPRINTING, MEDICAL EVALUATION CLEARANCE, AND FUNCTIONAL CAPACITY ASSESSMENT
Internal Number: 055545
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-term 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 eve...ryone 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.