Clinical Research Coordinator, Non Licensed

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 assuring 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
• Perform all study activities following Good Clinical Practices (GCP).
• Manage multiple clinical trials simultaneously.
• Protect the safety of human subjects.
• Assure all tests required by the study are executed.
• Obtain Informed Consent from Human Subjects.
• Obtain all data required for study.
• Monitor patient compliance.
• Obtain records and submit data including entering appropriate data into Database.
• Submit data in required time-frame.
• Monitor appropriate sources for specific clinical study or federal regulation updates.
• Complete Case Report Forms.
• Facilitate audits of study data.
• Develop patient rapport in order to explain research protocols and minimize protocol violations.
• Develop rapport with study team to educate team on study procedures and minimize protocol violations.
• Respond to inquiries by auditors for data clarification or additional data in required time-frame.
Coordinate and Perform Pre-Study and Close-Out Activities
• Coordinate and attend site evaluation and initiation meetings.
• Advertise, recruit, and screen patients for the study.
• Coordinate and attend the study close-out visit.
• Finalize all patient record entries.
• Finalize study material accountability and study files.
• Properly store and file study files.
Coordinate and Perform Regulatory Activities
• 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.
• Report adverse events relating to the trial.
• Maintain study files.
In addition to the above job responsibilities, other duties may be assigned.
Qualified candidates must have:
• Associate degree required
• Bachelor's Degree Preferred.
• 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 with 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.
To Apply:
Please apply through Workday , and search for R0053880 . Internal applicants must apply through their UVA Workday profile by searching 'Find Jobs' and search for R0053880 . Complete an application online with the following required documents:
• CV
• Cover letter
Upload all materials into the resume submission field, multiple documents can be submitted into this one field. Alternatively, merge all documents into one PDF for submission. Applications that do not contain all required documents will not receive full consideration.
References will be completed via UVA's standardized process Skill Survey. A total of five references will be requested via Skill Survey during the final phase of the interview process.
For questions about the application process, please contact Eric Allen, Academic Recruiter at uth9qh@virginia.edu
For more information about UVA and the Charlottesville community please see http://www.virginia.edu/life/charlottesville and https://embarkcva.com/ .
The University of Virginia, i ncluding the UVA Health System which represents the UVA Medical Center, Schools of Medicine and Nursing, UVA Physician's Group and the Claude Moore Health Sciences Library, are fundamentally committed to the diversity of our faculty and staff. We believe diversity is excellence expressing itself through every person's perspectives and lived experiences. We are equal opportunity and affirmative action employers. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender identity or expression, marital status, national or ethnic origin, political affiliation, race, religion, sex (including pregnancy), sexual orientation, veteran status, and family medical or genetic information.