Clinical Research Associate Location:
USF Health Regular/Temporary:
Regular Full/Part Time:
Full-Time Job ID:
Dept Number/Name: 0-6163-000 / Health Informatics Institute
College Division: USF Health-Morsani College of Medicine
Salary Plan: Administrative (Grant Funded)
Job Code/Title: 4728 / Clinical Research Associate
Hiring Salary/Salary Range: $50,000 -$55,000 annual
Position Number: 00034991
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 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.
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.
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 site research staff. Coordinate conference calls and meetings and prepare necessary meeting documents (agendas, minutes, handouts, reports, etc.), develop related standards, templates and processes. Develop and maintain policies, templates, and related documents to support study.
Manage clinical center, site, and research staff communication and documents. Receive, review for appropriateness, and file Institutional Review Board (IRB) approvals and essential regulatory documents for research centers. Update protocols as needed and maintain document version control. Coordinate the drafting and updating of general system user documentation. Coordinate IRB/regulatory submissions for the DCC and for the project/network.
Oversee and assist in protocol and Manual of Operations (MOO) 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 and maintain MOO, research protocol, and other study resources/training documents. Coordinate with DCC Project Lead and Study Chair in preparation of final documents for research staff training. Track changes in protocol, MOO, study resources/training documents, reports, and form requirements.
Attend study group and study committee meetings/calls as requested 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 DCC Project Lead. Follow-through with any meeting/call related requests 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.
Develop and interpret policy governing data systems, data collection procedures and database validation studies to be in compliance with federal guidelines (e.g. HIPAA, Good Clinical Practice). Review accumulating data and communicate with site research staff regarding data quality and data completeness. Monitor data compliance by clinical sites, reporting findings to the DCC project lead and study investigator. Ensure quality of study data through identification, evaluation and resolution of discrepancies and other efforts to reduce data errors by researchers.
Participate in site visits as needed. 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.
Performs other duties as assigned.
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.
Master's degree in the same field and two years of experience preferred.
Information for Applicants
This position is subject to a Level 1 criminal background check.
Job Opening Number: 30531
Posting Date: 04/22/2022
Posting End Date: 05/06/2022
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