DescriptionThe Senior Clinical Research Coordinator contributes to the overall operational management of clinical research/trial/study activities from design, set up, conduct, through closeout. The position has responsibility for the implementation of research activities for one or more studies. The incumbent recognizes and performs necessary tasks to manage projects and prioritizes work to meet necessary deadlines. The incumbent is responsible for planning and organizing necessary tasks to ensure adherence to the study protocol and applicable regulations, such as institutional policy and procedures, FDA Code of Federal Regulations (CFR), and ICH Good Clinical Practice (GCP). The Senior Study Coordinator collaborates with the Principal Investigator (PI), ancillary departments, central research infrastructure teams, sponsors, institutions, and other entities as needed to support the administration of all aspects of studies, including, but not limited to, compliant conduct, financial management, and adequate personnel support. The responsibilities outlined in the job description provide a general overview of duties and tasks performed by Clinical Research Coordinators. Performance of duties and tasks will vary based on the department operations, the type of study and scope of service.QualificationsRequired:Minimum of 4+ years of experience in a clinical research settingInterpersonal skills to effectively communicate information in a timely, professionalmanner and establish and maintain cooperative and effective working relationships withstudents, staff, faculty, external collaborators and administration and to work as amember of a team.Ability to effectively communicate to and interact with patients in a compassionate andkind manner.Ability to set priorities and complete ongoing tasks with competing deadlines, withfrequent interruptions, to meet the programmatic and department needs, while complyingwith applicable University policies and federal and state regulations.Analytical skills to assess clinical research protocols and regulatory requirements, defineproblems, formulate logical solutions, develop alternative solutions, makerecommendations, and initiate corrective actions.Close attention to detail to ensure accuracy in a fast-paced, fluctuating workloadenvironment.Organization skills to create and maintain administrative and regulatory files effectivelyas well as independently balance the various tasks to ensure deadlines are met.Demonstrated proficiency with Adobe and Microsoft suite software, especially Excel, toperform daily tasks efficiently and accurately.A learning and professional growth mentality so that new software tools, systems, and processes can be adopted quickly and efficiently.Knowledge of and experience working with a variety of local and external IRBs, scientificreview and other research committees, national cooperative group sponsors, industrysponsors, federal and foundation funding organizations, etc.Strong verbal and written communication skills to effectively establish rapport, buildingcollaborative relationships, and communicate complex concepts and ideas in an easy-tounderstandmanner.Ability to adapt to changing job demands and priorities, remain flexible including workingflexible hours to accommodate research deadlines.Ability to handle confidential information with judgement and discretion. All RequiredHigh degree of concentration and focus in a work environment that contains distractingstimuli, competing deadlines, and work delegated by more than one individual.Availability to work in more than one environment, travelling to various clinic sites,meetings, conferences, etcStrong knowledge of and experience working with a variety of local and external IRBs,scientific review and other research committees, national cooperative group sponsors,industry sponsors, federal and foundation funding organizations, etc.Strong knowledge of clinical research concepts, policies and procedures, and humansafety protection regulations and laws.Ability to think creatively to develop solutions affecting the full team. All RequiredExperience with FDA processes and procedures.Sufficient experience and knowledge of clinical trials budgeting processes to manage thepreparation of clinical trials budgets -Bachelor's degree required, Master's degree preferredUCLA Health welcomes all individuals, without regard to race, sex, sexual orientation, gender identity, religion, national origin or disabilities, and we proudly look to each person’s unique achievements and experiences to further set us apart.
