• This position must be familiar with current research protocol guidelines and assist with reviewing new protocols.
• Responsible for recruiting and entering eligible candidates into research studies after reviewing the risks and benefits of the study and by obtaining informed consent.
• Responsible for screening and obtaining accurate and complete medical history and collecting, documenting and maintaining accurate patient records.
• Responsible for preparing reports to the Institutional Review Board in a timely manner.
• Preparation of documents required for initial submission to UF research offices and for the sponsor.  Preparing and submitting regulatory documents for revisions and for continuing review.
• Identify potential research study participants with the assistance of the Principal Investigator and clinical trials research staff. Recruit participants via methods approved by the IRB.  This includes participation in community health fairs and educational events which are may be held in the evenings and on weekends.
• Help to determine creative and effective ways to educate the community regarding clinical research studies. 
• Communicate with subjects participating in studies via telephone, email and/ or in person to gather necessary research information, schedule appointments, remind subjects of any protocol pre-testing requirements, and address questions and concerns.
• Prepare and compile necessary items for research study appointment such as participant's schedule, data collection forms, sample kits, etc.
• Schedule research study subject visits in the Clinical Research Center (CRC) and with any other necessary clinic or ancillary offices.
• Coordinate with Investigational Pharmacy for study visits requiring study drugs and arrange for orders and dispensing.
• Develop Informed Consent, allowing appropriate time for subject to read, understand, ask questions and have them answered.

Clinical Trials 
• Assist Principal Investigator with all study related duties
• Patient recruitment and Developing advertisement materials
• Obtaining Informed Consents
• Review lab reports and communicate results with study clinicians
• Appropriately assesses and documents adverse events
• Implements systems of clinician communication to ensure safe management of study    patients
• Dispensing Investigational drug products
• Monitoring of subjects enrolled in trials in accordance with medical and health management standards, study protocols and GCP/ICH guidelines
• Participate with finance team in the tracking and management of study finances including sponsor invoicing & resolving study subject billing issues and in compliance with study specific budgets
• Participate in developing budgets
• Participates in the development and conduct of study billing plans.
• Develop advertisement materials
• Act as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals
• Document investigational product (drug/device) accountability
• Self-monitor and self-audit responsibilities
• Develop Case Report Forms/source documents
• Participates in promoting Human Subjects Protections within Clinical Research areas
• Obtains vitals signs and collected study samples
• Sample processing
• Provide back-up coverage for other research coordinators’ studies within the Division as needed
• Manage essential regulatory documents
• Filing source documents
• Communicate with finance team about management of HSP payment tracking and compliance with study budgets
• Maintain assigned databases/lab flowsheets for clinical care.
• Submit documents to regulatory authorities (e.g. IRB, FDA, etc.) and/or review/monitoring boards (ie, DSMB, independent safety officer)
• Facilitate study close out activities
• Schedule subject visits and procedures
• Retain records/archive documents after study close out
• Participates in promoting Human Subjects Protections within Clinical Research area