Job Title Clinical Research Associate Job ID 16734 Location USF Health Full/Part Time Full-Time Regular/Temporary Regular Position Details Dept. Number/Name: 0-6163-000 / Health Informatics Institute College Division: USF Health- Morsani College of Medicine Salary Plan: Administrative Job Code/Title: 4728 / Clinical Research Associate Hiring Salary/Salary Range: $50,000 - Negotiable Position Number: 00034990 and 00034991 ORGANIZATIONAL SUMMARY: The Health Informatics Institute (HII) is comprised of approximately 150 members consisting of biostatisticians and bioinformaticians; epidemiologists; software, data, and systems engineers; solution and data architects; laboratory and clinical research associates; and administrative staff. Established in 2004 as the Pediatric Epidemiology center, the annual budget of the institute currently exceeds $50 million, primarily in national Institutes of Health (NIH) funding. Faculty areas of expertise include biostatistics applied to pre-clinical, clinical, observational, and population health research; biomedical and clinical informatics; and statistical genetics and genomics. Members are engaged in research focused on the prevention of diabetes and other autoimmune diseases, cancer prevention and control, genetic disorders, and an expanding list of rare diseases. The primary mission of the HII is to establish and maintain expertise in biomedical science, statistics, clinical trial and study design and coordination, software and data engineering, big data and high performance computing, and integrative bioinformatics. This expertise is leveraged to act as an integrative force in bringing together clinical and biological data with results from diverse fields, applications, and enterprises. In doing so, we endeavor to support the investigation of disease etiology, prevention, and treatment in a comprehensive and transdisciplinary fashion. POSITION SUMMARY: This individual will have responsibility for the management and coordination of clinical trials within the Data Coordinating Centers at the HII. Serve as staff liaison between network sites, laboratories, biorepositories, supply vendors, and the data coordinating center (DCC), coordinate dissemination of information between the DCC and study researchers, and respond to questions. Prepare initial training and oversee ongoing training of research staff on systems and tools. Act as point of contact and support for consortia research staff. Coordinate conference calls and meetings and prepare necessary meeting documents (agendas, minutes, handouts, reports, etc.), develop related standards, templates and processes. Manage addition of new sites to the network and develop and maintain policies, templates, and related documents for new site additions. RESPONSIBILITIES: * Serve as staff liaison between network sites and the data coordinating center (DCC), coordinate dissemination of information between the DCC and study researchers, and respond to questions. Prepare initial training and oversee ongoing training of research staff on systems and tools. Act as point of contact and support for consortia research staff. Coordinate conference calls and meetings and prepare necessary meeting documents (agendas, minutes, handouts, reports, etc.), develop related standards, templates and processes. Manage addition of new sites to the network and develop and maintain policies, templates, and related documents for new site additions. * Manage clinical center, site, and research staff communication and documents. Receive, review for appropriateness, and file Institutional Review Board approvals and essential regulatory documents from consortia clinical centers. Update protocols as needed and maintain document version control. Coordinate the drafting and updating of general system user documentation. Coordinate Institutional Review Board (IRB) submissions for the HII DCCs and for the project/network. Manage and develop policies for Western Institutional Review Board (WIRB), Investigational New Drug (IND), and Certificate of Confidentiality submissions. * Participate in auditing site visits as needed. Develop training materials for the audit team. As a member of the audit team, review regulatory documents and files for appropriateness and completeness. Review case report forms, source documentation, medical records and research charts for data integrity and completeness. * Oversee and assist in protocol development and electronic case report form (eCRF) design; obtain and maintain regulatory compliance approval for the grant as a whole to ensure compliance to all standards, policies and quality measures. Develop Manual of Operations (MOO) document: review medical protocol and prepare draft of document; coordinate with protocol Project Manager and Study Chair preparation of final document for research staff training. Throughout the tenure of the medical protocol, update as needed with Study Chair as appropriate. Track changes in protocol requirements and form definitions. * Develop and interpret policy governing data systems, data collection procedures and database validation studies to be in compliance with federal guidelines (Good Clinical Practice, GCP). Review accumulating data and communicate with site staff at the consortia or local clinical sites regarding data quality and data completeness. Monitor data compliance by clinical sites, reporting findings to the study investigator. Ensure quality of study data through identification, evaluation and resolution of discrepancies and other efforts to reduce data errors by researchers. * Attend consortium and steering committee meetings to represent the DCC and be a source of information for any questions that may arise. Report requests and solutions to those requests to the Director. Follow-through with any meeting related request to ensure proper implementation. * Obtain management and client agreement with the project plan and timeline, and advise of any obstacles or resource needs that may affect completion of the project as planned. Apply project management tools and tracking systems to manage all aspects of project progress. * Special Projects as needed. POSITION QUALIFICATIONS: MINIMUM: * This position requires a Bachelor's degree in a field directly related to the program responsibilities and one year of professional experience; or Master's degree in an area of specialization appropriate for the program. PREFERRED: * Master's degree in the same field and two years experience preferred. Are you interested in clinical job opportunities with the USF Health Care working for University Medical Service Association, Inc. (UMSA)? Visit https://usfpgcareersource.health.usf.edu/ for more information. Information for Applicants This position is subject to a criminal background check. Posting End Date: Open Until Filled