Clinical Research Coordinator II

2 weeks ago

Gainesville, United States University of Florida Full time

Classification Title:

Clinical Research Coordinator II

Job Description:

The Department of Orthopaedics is seeking a Clinical Research Coordinator to join our team. The incumbent of this position will be an integral member of our research team. The incumbent is responsible for collecting clinical data for various studies by screening patients in clinic. This is a "hands on" position with interface with patients and physicians. The coordinator will participate in a wide range of activities, with duties that include: performing data entry; collecting patient data; creating, collecting and processing clinical surveys, assessments and questionnaires; and collecting patient measurements (including range of motion, strength measurements and other outcome data). He/she attends research meetings and communicates study progress to the research team. The coordinator ensures communication among internal and external referring physicians and members of the Health Care Team. He/she communicates and interprets policies and procedures to members of the healthcare team, patients, families and visitors to ensure regulatory compliance and subject safety.

Responsibilities will include:

* Coordinate Institutional Review Board(IRB) and Clinical Trials Compliance (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. Works in Microsoft Word, Microsoft Excel and image processing software programs. 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.


* COMMUNICATION. 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.


* Performs other duties as requested to assure the timely completion of tasks necessary for the efficient operation of the Department of Orthopaedics.

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