3, Neurosurgery

UVA Health•Charlottesville, VA

1d•Onsite

About The Position

The Department of Neurosurgery, at the University of Virginia School of Medicine, is currently seeking applicants for Clinical Research Coordinator 2/3, Non-Licensed positions. 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/.

Requirements

Bachelor's Degree Required or equivalent combination of experience, education and or certifications.
At least one year of clinical research experience (for CRC 2).
Minimum of 3 years of clinical research experience required (for CRC 3).
Master’s degree may substitute for 1 year of clinical research experience (for CRC 3).

Nice To Haves

Some experience in a healthcare setting and/or knowledge of medical terminology is preferred.
Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is preferred at the time of hire and is required within one year.

Responsibilities

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 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.
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.