Job location: Charlottesville, VA Employment Type:
Full-time Posted data:
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.
E. Additional Duties as Assigned
- 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.
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 position will remain open until filled. 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. For questions about the position or the application process, please contact Ashley Cochran, Senior Recruiter at firstname.lastname@example.org.
How to Apply:
Applications that do not contain all of the required documents will not receive full consideration, please note that multiple documents can be uploaded in the box.
Process for External Applicants: Please apply through Workday, and search for R0027686 . Complete an application online and attach a cover letter, CV/resume, and contact information for three references (name, email address, telephone number, and address).
Process for Internal UVA Applicants: Please apply through your Workday Home page, search “Find Jobs,” and search for R0016556. Complete an application online and attach a cover letter, CV/resume, and contact information for three references (name, email address, telephone number, and address).
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.
The University of Virginia, including 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.