Clinical Research Coord II
Job no: 515467
Work type: Staff Part-Time
Location: Main Campus (Gainesville, FL)
Department:29051300 - MD-NEPHROLOGY
Advertised: 12 Jan 2021 Eastern Standard Time
Applications close: 19 Jan 2021 Eastern Standard Time
Clinical Research Coordinator IIJob Description:
The Department of Medicine, Division of Nephrology, Hypertension & Renal Transplantation is looking to fill a Clinical Research Coordinator II position. The Clinical Research Program Coordinator 2 for the Division of Nephrology will participate in all aspects related to coordination of clinical research. This position will work with Division investigators and the clinical trials director and staff to coordinate clinical studies within the Division, both general nephrology and transplant. The duties for this position include but not limited to:
• 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. Assist in 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 and recruit them via methods approved by the IRB. This may occasionally include participation in community health fairs and educational events which are sometimes held in the evenings and on weekend days.
• 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.
• Collaborate with Principal Investigator on 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
• Assist 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
• Assists finance team with 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
$35,760 - $38,400Minimum Requirements:
Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.Preferred Qualifications:
Prior experience with clinical research.
Experience with MS Word, Excel, and data management preferred (InForm, REDCap, and Oncore)
EPIC EMR System
Upload CV for consideration for this position.This is a time-limited position.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.Health Assessment Required: