Clinical Research Coordinator III Job no: 509201 Work type: Staff Full-Time Location: Main Campus (Gainesville, FL) Categories: Research/Scientific/Grants Department:29091100 - MD-PEDS-GENETICS Classification Title: Clinical Research Coordinator III Job Description: This position is located in Pediatric Genetics Division and serves to coordinate, support and grow clinical trial activities in the Division. The Coordinator plays an active, expert level role in setting up policies, procedures and workflow processes. The applicant must be comfortable and competent in working specifically children and their families enrolled into experimental therapeutic research studies. - Protocol submissions and subject recruitment for assigned studies: Acts in an advocate/liaison role to ensure the timely opening of assigned studies for patient enrollment, the accrual of patients and supervision of appropriate study close-out procedures. Collaborates with internal and external regulatory bodies: Research administration and compliance (RAC), Institutional Review Board (IRB), CTSI, FDA and GCRC staff to ensure all regulatory documents are appropriately submitted and kept up to date. Maintains a friendly and constructive relationship with staff in these regulatory bodies. Submits accurate Institutional Review Board documents for new and on-going studies such as continuing review/study closure reports, serious adverse event reports, and protocol addenda. Attends Institutional Review Board meetings and professionally responds to questions from the Board or IRB staff. Attends appropriate meetings/rounds and prepares and/or presents requested information. Assists in maintenance of up-to-date comprehensive regulatory and/or study binders. Provides sponsors with updated regulatory documents. Independently coordinates and oversees all aspects of clinical research trials by identifying possible clinical trial candidates through attendance at patient rounds, patient care conferences, interviewing patients and/or reviewing medical records. The incumbent will also interpret medical information and other source documentation to confirm subject eligibility for clinical trial participation. Incumbent responsible for educating subjects, caregivers and/or legally authorized representatives about the purpose of the pertinent clinical trial, testing procedures, visit schedule, completion of study required documents, potential side effects and potential financial implications. Incumbent will review informed consent documents and answer questions about informed consent content with subjects, caregivers and/or legally authorized representatives. - Coordination of subject visits and procedures: Incumbent will accurately communicate all protocol-specific requirements and protocol-required modifications with key personnel such as Physicians, Physician Assistants, Pharmacists and Nurses, both inpatient and outpatient. The incumbent will work closely with physicians to coordinate and manage care of children, adolescents and young adults. She/he will work closely with the physicians to oversee patient management, including identifying and evaluating illnesses and injuries, treating common illnesses, and monitoring the progress of acute and chronic illnesses. The incumbent will also be responsible for the accurate interpretation of test results and accurately communicating these to subjects and staff, evaluating and grading toxicities, extracting protocol-required data from medical records, including medical history, diagnosis, pathology, laboratory, radiology, specialty test results, progress notes and reported side effects or adverse reactions. The incumbent will review protocol and subject data with Principal Investigators and sub-investigators as needed and accurately enter data on paper or electronic case report forms for each sponsor and collaborate with investigators and monitors to resolve case report form discrepancies or queries. Responsible for the financial management of the studies to include review of study invoices from hospital and other vendors and approval for payment. Works with Pediatrics Grants office staff to ensure accurate billing of study costs to the contracting agency and tracking receipts of payments for this site and other satellite sites that may participate under the administrative overview of the University of Florida. Coordinate with Pediatric Department and with RAC for this purpose. Accountable to the PI for this purpose. Incumbent will plan and conduct services on assigned clinical trials to disseminate protocol information and prepare pre-printed study orders and study information sheets and secure appropriate approvals as indicated. Incumbent will also create on-study reference materials (eg, PK schedules, PD schedules, and dictation checklists), IDS forms (if applicable) and other tools to insure that patient safety and protocol compliance. - IRB and RAC packets: Assists PIs for assigned studies with Informed Consent Drafting. Responsible for knowledge of rules and submission requirements to the local and central Review Boards. Works closely with the UF IRB to be updated on requirements and changes. May be required to assist with Informed Consent Drafting for protocols where ICF is not provided by the sponsor. Coordinates and ensures that FLA language for the informed consent as provided by the College of Medicine RAC office, is inserted in the ICF submitted to the IRB. Reviews final clinical trial contract terms to ensure that final version is consistent with the approved ICF. Responsible for understanding of CPT codes and careful selection of codes for the COS requests. Knowledgeable of the COS process flow and required contacts throughout the UF&Shands Academic Health Science Center. Verifies selected codes with trial coordinators and/or ancillary personnel. Advertised Salary: $65,000 - $75,000 annually; commensurate within this range based on experience and education. Minimum Requirements: Bachelor's degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience. Preferred Qualifications: - Registered Nurse. - Several years of clinical research trial experience. - Advanced knowledge and experience with clinical trial research process and policies. - Excellent interpersonal skills; ability to work independently, solve problems and make appropriate decisions. Special Instructions to Applicants: This is a time-limited position. To be considered for this position, please upload your cover letter or letter of interest, resume and a list of 3 professional references. Normal work hours are Monday through Friday, 8:00am to 5:00pm; with occasional after hours or weekend work. The University of Florida is an equal Opportunity Employer dedicated to building a broadly diverse and inclusive faculty and staff. Application must be submitted by 11:55 p.m. (ET) of the posting end date. Health Assessment Required: Yes Advertised: 07 Nov 2018 Eastern Standard Time Applications close: 14 Nov 2018 Eastern Standard Time