The Senior Clinical Research Coordinator (Sr. CRC) provides support, coordination, and leadership for industry sponsored clinical research, government sponsored clinical research, and investigator initiated clinical research within the Department of Orthopaedic Surgery. This position ensures smooth, accurate progress of clinical studies from the planning and approval stages, through study completion and post-study closure. The incumbent prepares documentation for submission for review by the Institutional Review Board (IRB), recruits and screens study participants, coordinates the clinical treatment and follow-up care as it pertains to study protocol, and facilitates continued participation. The Sr. CRC also abstracts data from medical records and other sources; collects, submits and maintains study data and regulatory documents; develops and ensures compliance with study protocols; and participates in the planning, development and budgeting of clinical studies. The Sr. CRC provides leadership for a department-wide clinical research program, including guiding and mentoring clinical research coordinators, associates, and/or other support personnel.REQUIRED- Society for Clinical Research Associates (SOCRA) Certified Clinical Research Professional (CCRP) or Association of Clinical Research Professional (ACRP) Certified Clinical Research Coordinator (CCRC)- Advanced knowledge of regulatory processes as well as a working knowledge of data management activities.- Advanced-level knowledge of federal, local, and institutional regulatory guidelines.- Thorough knowledge of regulations related to FDA, state & federal guidelines, and Good Clinical Practices, for drug and device studies (clinical research involving human subjects).- Advanced-level knowledge of basic anatomy, medical terminology and ability to interpret physicians' notes, medical records, laboratory and scan results.- Advanced analytical skills to evaluate information, practices and procedures, formulate logical and objective conclusions and make recommendations for effective solutions. - Administrative skills and ability to exercise good judgment, initiative and resourcefulness in making decisions.- Experience and working knowledge of but not limited to: scheduling and medical record systems, Microsoft Word, Excel, Access and etc.- Demonstrate oral and written communication skills, including skills to compose reports and correspondence while utilizing correct grammar, spelling and punctuation as well as clearly documenting research data onto forms.PREFERRED- Advanced-level knowledge and understanding of orthopaedics, orthopaedic diagnosis, disorders and treatments as applied to clinical research.- Leadership skills and mentor experience.- Experience working individually and as a team member in a diverse workforce.SPECIAL REQUIREMENTS - THIS POSITION MAY BE SUBJECT TO A CRIMINAL BACKGROUND INVESTIGATION, DRUG SCREEN, LIVE SCAN FINGERPRINTING, MEDICAL EVALUATION CLEARANCE, AND FUNCTIONAL CAPACITY ASSESSMENT.- Position may require working occasional overtime and traveling between local work locations as work demands. Travel (vehicle or airline) for training and educational purpose may also be required. - THIS IS NOT AN H1B OPPORTUNITY.
Internal Number: 053502
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.