The Department of Neurosurgery, at the University of Virginia School of Medicine, is currently seeking a Clinical Research Coordinator, non-licensed. The incumbent evaluates the feasibility of proposed trials, prepares and/or plans for the opening of trials, conducts trials, facilitates data capture, and audits multiple clinical trials. This is accomplished while ensuring patient safety and abiding by applicable federal law and international guidelines for the conduct of clinical trials. For more information on the Department of Neurosurgery Clinical Research, please visit:
https://med.virginia.edu/research/.
The successful candidate will be expected to:
Clinical Research Trials Coordination
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Perform all study activities following Good Clinical Practices (GCP).
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Manage multiple clinical trials simultaneously.
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Protect the safety of human subjects.
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Ensure all tests required by the study are executed.
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Obtain informed consent from human subjects.
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Obtain all data required for study.
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Monitor patient compliance.
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Obtain records and submit data, including entering appropriate data into database.
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Submit data in required time frame.
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Monitor appropriate sources for specific clinical study or federal regulation updates.
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Complete case report forms.
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Facilitate audits of study data.
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Develop patient rapport in order to explain research protocols and minimize protocol violations.
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Develop rapport with study team to educate team on study procedures and minimize protocol violations.
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Respond to inquiries by auditors for data clarification or additional data in required time frame.
Coordinate and Perform Pre-Study and Close-Out Activities
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Coordinate and attend site evaluation and initiation meetings.
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Advertise, recruit, and screen patients for the study.
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Coordinate and attend the study close-out visit.
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Finalize all patient record entries.
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Finalize study material accountability and study files.
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Properly store and file study files.
Coordinate and Perform Regulatory Activities
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Maintain proper protocol, consent, amendment, and yearly renewal submission to the Human Investigation Committee, General Clinical Research Center, Radiation Safety Committee, and the Office of Grants and Contracts.
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Report adverse events relating to the trial.
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Maintain study files.
In addition to the above job responsibilities, other duties may be assigned.
Qualified candidates must have:
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Associate's degree required.
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Bachelor's degree preferred.
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Four years of clinical research experience can be considered in lieu of a degree.
The Clinical Research Coordinator will report to the Director of Neurosurgery & Neuro-Oncology Clinical Research within the Department of Neurosurgery.
For additional information about the position, please contact Judy Beenhakker,
Director of Neurosurgery & Neuro-Oncology Clinical Research,
jgb3p@virginia.edu.
This is primarily a sedentary job involving extensive use of desktop computers.
This position is located in Charlottesville, VA.
This is an exempt-level, benefited position. For more information on the benefits at UVA, visit
hr.virginia.edu/benefits.
This position will remain open until filled. This position will not sponsor applicants for work visas. The University will perform background checks on all new hires prior to employment. A completed pre-employment health screen is required for this position prior to employment.
For more information about UVA and the Charlottesville community, please see
http://www.virginia.edu/life/charlottesville and
https://embarkcva.com/.
COVID Vaccination Requirement and Guidelines
Please visit the UVA COVID-19 Job Requirements and Guidelines webpage prior to applying for current information regarding vaccination requirements and guidelines for employment at UVA.