The purpose of the Research Operations Associate (ROA) is to provide simultaneous project coordination and data management for approximately 10 to 12 research projects. The ROA must have the ability to proactively organize and independently manage workload, to meet all deadlines in a complex environment.
Under the direction of the Clinical Trials Group (CTG) Associate Director of Clinical Operations, the ROA works closely with Study Management Teams, principal investigators, research site personnel, and study sponsors. The ROA must be able to assimilate complex scientific information and technology in order to monitor, track, compile, and analyze specific research project data. They are also responsible for reconciling data discrepancies in order to ensure data is up-to-date and accurate within ITN research databases and systems.
The ROA is responsible for working closely with the Research Operations Managers to prepare meeting agendas and content for research team meetings, as well as draft meeting minutes. In addition, the ROA is responsible for development of detailed project - specific management tools, such as manuals of procedures, forms, source documents. Development of these documents requires research and consultation with content experts. The ROA also provides training and support to research study sites, and plans and coordinates project-related conferences and meetings as directed.
IMMUNE TOLERANCE NETWORK
The Immune Tolerance Network (ITN) is a National Institutes of Health funded international consortium to facilitate the advancement of clinical trials at all phases to determine the safety, toxicity and efficacy of promising tolerogenic strategies in islet, kidney and liver transplantation, autoimmune diseases and allergy u0026 asthma. The ITN develops and conducts collaborative research projects between academic, governmental and industry researchers which are based on cutting edge immune tolerance research that could not otherwise be conducted. Projects overarch all phases of research and development, are complex (novel assessments/ interventions), include many stakeholders, and require multiple- sub-contracts which comprise multi-million dollar budgets for a single project.
The ITN Clinical Trials Group (CTG) acts as a fully functioning Clinical Research Organization (CRO) and is centrally responsible for the development, implementation, and management of all research projects conducted by the ITN. The CTG supports scientific, technical, operational, and administrative functions, including project development, project management, regulatory support, implementation, oversight, and data analysis for the network.
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: High school graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities
Possess extensive proficiency in computer software and systems including Office Suite (Word, Excel, PowerPoint, Visio, Endnote, Outlook) and working knowledge of MS Project
Basic knowledge of regulatory guidelines and directives
Proficient knowledge of research operations requirements involving human subject research, IRB (CHR at UCSF and similar groups at other institutions involved in research sponsored by the ITN), FDA, and international regulatory bodies requirements
Ability to manage, format, and QC complex documents (e.g. protocols, ICFs, Manuals of Procedures, Scopes of Work, reports etc.)
Ability to collect and integrate large amounts of information from multiple sources so it can be compiled and presented in an accurate and concise format
Ability to analyze and simplify complex information
Ability to operate independently in the areas of immediate responsibility. The ability to follow directions, exercise sound timely judgment and take relevant responsible action as required, with considerable attention to detail and accuracy
Excellent interpersonal, oral and written communication in English, and negotiation skills in order to maintain strategic partnerships, motivate and act professionally with external constituents, trial investigators, vendors, ITN staff, and NIAID representatives
Demonstrated ability to set and keep timelines, and coordinate large numbers of people or projects across different locations
Strong organization, analytical, critical, and innovative problem solving skills; demonstrated ability to conduct analyses and develop recommendations
Experience working effectively via telecommunication with external constituents and sites, without disruption to flow of work, and using established, approved, and secure communication procedures
Demonstrated ability to direct others within a matrix environment
Ability to independently set priorities, anticipate impediments, and implement solutions to manage assigned activities, meet goals and objectives according to projected timelines
Excellent oral and written communication including the ability to clearly communicate in English, both orally and in writing
Ability to travel to annual meetings, conferences and investigative sites (one to two times per year)
Preferred Qualifications: BA/BS degree with a major in a related field and three years of experience in clinical research, administrative analysis or operations research; or an equivalent combination of education and experience
Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals, or the ability to obtain within one year of date of hire
Knowledge and experience of GCP, Human Subject Protections, and FDA/ICH guidelines
Research (CCRP, CCRC, CCRA) and/or Project Management (PMP, Six Sigma) Certification
Significant experience in planning, implementing, tracking, and managing complex multi-center clinical trials
Basic knowledge of medical therapeutic area and proficiency in medical/scientific terminology
Equal Employment Opportunity: The University of California San Francisco is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
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