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The Department of Medicine, Division of Gastroenterology Research is seeking a full time Clinical Research Coordinator III. This position is primarily responsible for coordination of clinical trials in the Hepatology Research Unit.
Essential Functions;
– Clinical Research Trials Coordination
• Coordinates research studies and special projects as directed.
• Support any PI sponsored Investigational New Drug (IND) or Investigational Device Exemption (IDE) Host/ prepare for external audits (sponsor, FDA, NIH, etc.)
• Study drug storage and dispensation in compliance with individual drug requirements and unit SOP’s
• Document investigational product (drug/device) accountability
• Monitoring of subjects enrolled in trials in accordance with protocols and ICH/GCP guidelines
• Patient assessment and care monitoring for changes and complications providing for appropriate physician-based care
• Review of laboratory results providing for physician input on abnormalities or referral for additional work-up.
• Participates in direct subject care via collection of vital signs, ECGs, FibroScans, concomitant medication, adverse events, as well as other protocol required procedures.
• Collect and process biospecimens.
• Provide appropriate patient teaching for protocol adherence and understanding of their underlying disease/disease management
• Accesses medical records from Epic for medical history as well as results on diagnostic studies, labs, surgical pathology, clinic notes, etc.
• Develops and analyzes Clinical Research activities for volunteer participants and makes changes in methods and procedures as necessary
• Liaison for hospital billing for research subjects
• Screen, recruit, and enroll research participants.
• Conduct and document Informed Consent process of study subjects
• Schedule subject visits and study procedures
• Monitor and audit studies research binders
• Liaison for research sponsors, central lab, and research participants
• Ensures the safety of research and laboratory
• Performs related duties as required or deemed appropriate to the accomplishment of the responsibilities and functions of his/her area.
• Responsible for assisting in the interpretation and implementation of policies and procedures as they apply to assigned areas of responsibility. May recommend changes on policy/procedures as necessary.
• Comply with Institutional policies, SOPs and guidelines
• Must comply with federal, state, and sponsor policies
• Participates in promoting Human Subjects Protections within Clinical Research areas
– Data Entry
• Fills out source documentation and enters data in EDC
• Enters patient visits and procedures in UF’s OnCore Database
• EPIC documentation
– Regulatory/Clerical
• Maintain working knowledge of current code of federal regulations (CFR), GCP/ICH guidelines and apply to clinical trials practice.
• Assist with essential regulatory documents and IRB continued reviews
• Development of source documents to meet the requirements of each study protocol
• Assists finance team with management of HSP payments and subject visit tracking
• Facilitate study close out activities
• Retain records/archive documents after study close out
– Other duties as assigned
• Work with other research study staff involved in the research process for protocol and office needs
The position will also be responsible on an ad hoc basis for managing study sites to ensure all study data and specific medical record narrative data are submitted and abstracted into the respective study database. Will ensure all data is queried and tracked for each participating site as well as provide training and administrative support to the site staff members responsible for data submission.
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