Clinical Research Coordinator
Job ID: R0027686 | Clinical Research | Full time | Charlottesville, VA
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.

The Clinical Research Coordinator, Non Licensed, will be responsible for the following responsibilities and duties:

A. Clinical Research Trials Coordination

1. Perform all study activities following Good Clinical Practices (GCP).
2. Manage multiple clinical trials simultaneously.
3. Protect the safety of human subjects.
4. Assure all tests required by the study are executed.
5. Obtain Informed Consent from Human Subjects.
6. Obtain all data required for study.
7. Monitor patient compliance.
8. Obtain records and submit data including entering appropriate data into Database.
9. Submit data in required time-frame.
10. Monitor appropriate sources for specific clinical study or federal regulation updates.
11. Complete Case Report Forms.
12. Facilitate audits of study data.
13. Develop patient rapport in order to explain research protocols and minimize protocol violations.
14. Develop rapport with study team to educate team on study procedures and minimize protocol violations.
15. Respond to inquires by auditors for data clarification or additional data in required time-frame.

B. Coordinate and Perform Pre-Study and Close-Out Activities

1. Coordinate and attend site evaluation and initiation meetings.
2. Advertise, recruit, and screen patients for the study.
3. Coordinate and attend the study close-out visit.
4. Finalize all patient record entries.
5. Finalize study material accountability and study files.
6. Properly store and file study files.
 

C. Coordinate and Perform Regulatory Activities

1. 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.
2. Report adverse events relating to the trial.
3. Maintain study files.
 

D. Orientation and Training of New Clinical Research Personnel

1. Act as preceptor to new coordinators both in the Clinical Trials Office and outside the Office.

MINIMUM REQUIREMENTS:

  • Education:Bachelor's degree required.
  • Experience: At least one year.
  • Licensure: Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA) with four years experience will be considered in lieu of degree.

PHYSICAL DEMANDS:

This is primarily a sedentary job involving extensive use of desktop computers. The job does occasionally require walking some distance to attend meetings, and programs.

This is an Exempt level, benefited position. This is a restricted position contingent upon the continuation of funding. The University will perform background checks on all new hires prior to employment.


COVID Vaccination Requirement

Due to the scope of President Biden's Executive Order 14042 issued in early September, all University employees, including remote employees, must receive their final vaccination dose by January 4, 2022, unless they have a University-approved religious or medical exemption. The University has updated policy SEC-045 to reflect these new requirements.

If hired by the Academic Division, excluding School of Medicine, School of Nursing, UVA Physicians Group, and the Health Systems Library, you will be required to provide proof of vaccination or be willing to be vaccinated by January 4, 2022. Academic employees may apply for a University-approved medical or religious exemption.

Note: Some medical and safety-sensitive positions require vaccination and are not eligible for an exemption. For more information on how vaccination requirements will apply to you, please visit the UVA New Hire Vaccination Requirements webpage.


Charlottesville, VA
Charlottesville, VA 22908

Working here.

Careers at the University of Virginia reflect a wide breadth of professions, ranging from teaching to administration, IT professionals to financial analysis, research to grounds management, and talent recruiting to facilities management, among many others. Every person here — faculty, staff, student, healthcare professional — helps to advance our world-class institution, encompassing a larger mission of discovery and service.

Quality of Life

Charlottesville, Virginia is one of the nation’s most charming and picturesque places to live and work. Our area boasts many excellent restaurants, wineries and craft breweries; historic sites; Shenandoah National Park and Skyline Drive; and a great selection of homes in welcoming neighborhoods, as well as urban and rural locations. Public transportation is excellent, and you’re just a short drive from the beach or Washington, D.C.