The Department of Medicine, Division of Gastroenterology is seeking a full time Clinical Research Coordinator I. This position performs all Clinical Research Coordinator (CRC) Core responsibilities and additional responsibilities detailed below. The candidate must be able to function independently in a clinical research setting and responsible for the complete coordination of assigned clinical research activities. Displaying effective problem solving, writing, and communication skills are vital. Must have the ability to multi-task, working as part of a team or independently. The coordinator will work under the direct supervision of the GI Clinical Trials Manager.
- Clinical Research Trials Coordination
• Coordinates research studies and special projects as directed
• Communicate with Principal Investigator to fully understand all study-related duties
• Comply with Institutional policies, standard operating procedures (SOPs) and guidelines
• Screen, recruit and enroll research participants
• Document investigational product (drug/device) accountability
• Review and provide laboratory results for physician input on abnormalities or referral for additional work-up.
• Monitoring of subjects enrolled in trials in accordance with medical and health management standards, study protocols, and GCP/ICH guidelines
• Participates in direct subject care via the collection of vital signs, ECGs, FibroScans, concomitant medication, adverse events, as well as other protocol required procedures
• Accesses medical records from Epic for medical history as well as results on diagnostic studies, labs, surgical pathology, clinic notes, etc.
• Collect, process and ship laboratory specimens
• Conduct ongoing internal auditing of research charts and data of clinical trials
• Works in conjunction with the regulatory and compliance office in study activation, which includes feasibility review, organization of IDS, ancillary services, site qualification visit, and site Initiation Visit (SIV)
• Facilitate pre-study, site qualification, study initiation and monitoring visits.
• Act as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals
• Develop Case Report Forms/source documents
• Participates in promoting Human Subjects Protections within Clinical Research areas
• Maintain study source documents
• Apply good clinical practice (GCP) standards and regulatory compliance (including ICH guidelines and the Code of Federal Regulations
• Educate subjects and family on protocol, study intervention, study drug, dosing tools, etc.
- Data Entry and Abstraction
• Data entry into in EDC systems (RAVE, REDCap, Inform, etc.)
• Documents patient visits and procedures in UF’s OnCore Database
• Monitor and answer for data query delinquencies
• EPIC documentation
- Regulatory/Clerical
• Manage essential regulatory documents
• Filing source documents
• Manage 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 review/monitoring boards (i.e., DSMB, independent safety officer)
• Facilitate study closeout activities
• Schedule subject visits and procedures
• Retain records/archive documents after study closeout