| Job Description: | The Department of Orthopaedic Surgery and Sports Medicine is seeking an experienced Clinical Research Coordinator II to join the research team as an integral member of our growing unit. The successful incumbent will be responsible for the collection of clinical data for various studies by screening patients in the clinic, hospital or department research laboratory. This is an exciting hands-on position interfacing with patients and physicians in an orthopaedic setting. About this Role: - Coordinate Institutional Review Board and CTC requirements. Develop, edit, and format protocols, budgets to meet CTC requirements, consent forms, brochures, advertisements, telephone scripts, and introductory questionnaires.
- Maintain, on file, all protocols, consent forms, official award acceptance letters, IRB approval letters, signed consents for all trials, CRF’s, source documents. Performs data entry and filing of patient information/data; performs database maintenance and troubleshooting.
- Assists the Research Program Director and attending physicians in the development of research protocols. Prepare paperwork for divisional weekly and monthly conference meetings. Maintain accurate record of all IRB protocols for the entire department.
- Assign, conduct, and review internal research study audits. Supervise department’s internal audit system process to ensure all studies are following appropriate IRB guidelines. Assist with training new research staff and residents on regulations for conducting research at UF. Assist orthopaedic surgeons, residents and fellows with presentations and posters. Supervises research assistants, medical students, and volunteers in the Research Division.
- Coordinate data management for listed protocols. Creates and develops databases to store and organize patient data. Collect patient data related to clinical research protocols following established guidelines (HIPAA, IRB). Collect patient measurements, including range of motion, strength measurements and other outcome data. Perform basic statistics, create graphs, and create tables.
- Correspond with sponsoring companies and NIH-funded collaborative research programs on multi-institutional trials regarding:
- Inclusion/exclusion.
- Protocol.
- Documentation.
- Coordination of site visits.
- IRB status.
- Contracts and budget.
- Investigator meetings.
- CFR’s.
- Supplies and equipment.
- Correspond with referring physicians regarding Inclusion/Exclusion criteria of research candidates. Correspond with patients on our studies regarding any questions they have. Develop educational material for patients and referring physicians to promote patient accrual on clinical trials. Communicate with nursing staff and physician assistants regarding patient care per protocol. Communicate with primary investigators.
- Consents patients or meets with patients to explain the purpose of studies. Conducts telephone interviews with patients for research purposes. Train physician assistants (PAs) on how to implement the Own the Bone program in their respective clinics. Educate patients on how to prevent secondary fragility fractures utilizing ten standard of care measures.
- Create, collect, and process clinical surveys, assessments, and questionnaires. Makes suggestions to the supervisor and moves forward with policy changes as appropriate for the research division.
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