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Sr Clinical Research Associate

Company name
University of South Florida

Tampa, FL

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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: 4435 \/ Sr. Clinical Research Associate Hiring Salary\/Salary Range : $72,000 - Negotiable Position Number: 00035097 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: The primary purpose of this position is plan, organize, and manage the resources necessary to bring about the successful completion of specific clinical research project goals and objectives. In doing so, the Sr. Clinical Research Associate must assemble and manage the team assigned to the project; disseminate information regarding projects and their statuses; document procedures, resource documents, and training manuals for the given project; and, to be the overall decision maker for the given project. Train direct and\/or indirect reports on policies and procedures, operations, adverse event resolution, Data and Safety Monitoring Board and\/or Laboratory Monitoring calls\/meeting preparation, creation and review, case report form creation and review, site data adherence and compliance, etc. Serve as resource for questions for sites and other internal staff. The Sr. Clinical Research Associate will manage multiple projects at once and must practice time management skills while managing the project staff. RESPONSIBILITIES: 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. Train direct and\/or indirect reports on policies and procedures, operations, adverse event resolution, Data and Safety Monitoring Board calls\/meeting preparation, protocol creation and review, case report form creation and review, site data adherence and compliance, etc. Serve as resource for questions for sites and other internal staff. 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. Update the protocols as needed and maintain document version control. Throughout the tenure of the medical protocol, update as needed with Study Chair as appropriate. Track changes in protocol requirements and form definitions. Manage clinical center, site, and research staff communication and documents. 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. Coordinate and serve as project lead for special projects and initiatives for the overall good of the project and\/or grant. 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). Participate in writing and coordination of grant submissions as applicable. 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. Manage and develop policies for Western Institutional Review Board (WIRB), Investigational New Drug (IND), and Certificate of Confidentiality submissions. 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. Receive and review for appropriateness Institutional Review Board (IRB) approvals and essential regulatory documents from consortia clinical centers. Coordinate IRB submissions for the HII Data Coordinating Centers (DCC) and for the project\/network. 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. Special Projects as needed. POSITION QUALIFICATIONS: MINIMUM: \u00a0 This position requires a Bachelor's degree in a field directly related to the program responsibilities and three years of professional experience; or Master's degree in an area of specialization appropriate for the program and one year of professional experience. PREFERRED: \u00a0 Masters is preferred; professional clinical research certification is preferred. Experience in NIH-funded clinical trials research. Are you interested in clinical job opportunities with the USF Health Care working for University Medical Service Association, Inc. (UMSA)? 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University of South Florida
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Company Profile
The University of South Florida is a high-impact, global research university located in beautiful Tampa Bay on Florida's spectacular west coast. It is one of the largest public universities in the nation, and among the top 50 universities, public or private, for federal research expenditures. The university is one of only four Florida public universities classified by the Carnegie Foundation for the Advancement of Teaching in the top tier of research universities, a distinction attained by only 2.3 percent of all universities.

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