Description The Semel Institute is seeking an Assistant Clinical Research Coordinator to contribute to the overall operational management of clinical research / trial / study activities from design, set up, conduct, through closeout. In this role you will have responsibility for the coordination of research activities for one or more studies and you'll recognize and perform necessary tasks to coordinate projects and prioritizes work to meet necessary deadlines. You would also participate in 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). As the Study Coordinator you will collaborate 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. Performance of duties and tasks will vary based on the department operations, the type of study and scope of service but general duties include: Clinical Research Coordination + Coordinate research studies, identify participants according the IRB approved recruitment plan and Completes role-based training. + Attend study initiation meetings and participate in team and general staff training events (i.e., teleconferences, webcasts, and/or meetings). + Complete protocol required training as needed. + Provide ongoing communication to all stakeholders to ensure pertinent information is disseminated. + Timely response to and resolution of inquiries, both written and verbal, with the appropriate level of information for the request. + Maintain a service centered approach for both internal and external customers, ensuring a high level of quality, communication, and support. Data and Regulatory Management + Assist in developing the study informed consent form(s) and amending the informed consent form(s) as applicable. + Prepare and submit site or study-specific regulatory documents. + Track and maintain required case histories/ essential documents as defined by FDA CFR and GCP to ensure regulatory compliance. Assist with routine and audits performed by internal review committees and/or external stakeholders. + Ensure timely regulatory reporting and thorough documentation. + Develops and implements adequate Corrective and Preventative Action (CAPA) plans as needed. Training and Development + Completes role-based training. + Attend study initiation meetings and participate in team and general staff training events (i.e., + teleconferences, webcasts, and/or meetings). + Complete protocol required training as needed This position description is not intended to be a complete list of all responsibilities, duties or skills required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization. Pay Range: $27.08 - $43.55 Qualifications Required: + Minimum of 1+ years of experience in a clinical research setting + Interpersonal skills to effectively communicate information in a timely, professional manner and establish and maintain cooperative and effective working relationships with students, staff, faculty, external collaborators and administration and to work as a member of a team. + Ability to effectively communicate to and interact with patients in a compassionate and kind manner. + Ability to set priorities and complete ongoing tasks with competing deadlines, with frequent interruptions, to meet the programmatic and department needs, while complying with applicable University policies and federal and state regulations. + Analytical skills to assess clinical research protocols and regulatory requirements, define problems, formulate logical solutions, develop alternative solutions, make recommendations, and initiate corrective actions. + Close attention to detail to ensure accuracy in a fast-paced, fluctuating workload environment. + Organization skills to create and maintain administrative and regulatory files effectively as well as independently balance the various tasks to ensure deadlines are met. + Demonstrated proficiency with Adobe and Microsoft suite software, especially Excel, to perform 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. + Working knowledge of clinical research concepts, policies and procedures, and human safety protection regulations and laws. + 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 verbal and written communication skills to effectively establish rapport, building collaborative relationships, and communicate complex concepts and ideas in an easy-to understand manner. + Ability to adapt to changing job demands and priorities, remain flexible including working flexible hours to accommodate research deadlines. + Ability to handle confidential information with judgement and discretion. + High degree of concentration and focus in a work environment that contains distracting stimuli, 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, etc. Preferred: + Bachelor's degree. 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