Clinical Research Coordinator 1/2/3, Neurosurgery

This position is located in Charlottesville, VA and must be performed fully on-site. A background check, pre-employment health screening, and drug screening will be conducted prior to employment. This is a restricted, benefited position dependent on funding availability.

About the Role

The Department of Neurosurgery at the University of Virginia School of Medicine is seeking applicants for Clinical Research Coordinator 2/3 (Non-Licensed) positions. The incumbent evaluates the feasibility of proposed trials, prepares for the opening of trials, conducts trials, facilitates data capture, and audits multiple clinical trials while ensuring patient safety and compliance with applicable federal laws and international guidelines.

For more information on the Department of Neurosurgery Clinical Research, visit UVA Neurosurgery Research.

Responsibilities

Clinical Research Trials Coordination

• Perform all study activities following Good Clinical Practices (GCP).
• Manage multiple clinical trials simultaneously.
• Protect the safety of human subjects.
• Ensure all tests required by the study are executed.
• Obtain informed consent from human subjects.
• Collect all data required for the study.
• Monitor patient compliance.
• Obtain records and submit data, including entering appropriate data into databases.
• Submit data within the required timeframe.
• Monitor appropriate sources for updates on clinical studies or federal regulations.
• Complete Case Report Forms.
• Facilitate audits of study data.
• Develop patient rapport to explain research protocols and minimize protocol violations.
• Develop rapport with the study team to educate them on study procedures and minimize protocol violations.
• Respond to inquiries by auditors for data clarification or additional data within the required timeframe.

Pre-Study and Close-Out Activities

• Coordinate and attend site evaluation and initiation meetings.
• Advertise, recruit, and screen patients for studies.
• Coordinate and attend study close-out visits.
• Finalize all patient record entries.
• Finalize study material accountability and study files.
• Properly store and file study files.

Regulatory Activities

• Maintain proper protocol, consent, amendment, and yearly renewal submissions 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 responsibilities, other duties may be assigned.

Requirements

Clinical Research Coordinator 1, Non-Licensed

• Education: Bachelor’s degree required or equivalent combination of experience, education, and/or certifications.
• Experience: None required. Some experience in a healthcare setting and/or knowledge of medical terminology is preferred.

Clinical Research Coordinator 2, Non-Licensed

• Education: Bachelor’s degree required or equivalent combination of experience, education, and/or certifications.
• Experience: At least one year of clinical research experience. Some experience in a healthcare setting and/or knowledge of medical terminology is preferred.

Clinical Research Coordinator 3, Non-Licensed

• Education: Bachelor’s degree required or equivalent combination of experience, education, and/or certifications.
• Experience: Minimum of 3 years of clinical research experience required. A master’s degree may substitute for 1 year of clinical research experience.
• Certification as a Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is preferred at the time of hire and required within one year.

Physical Demands

This is primarily a sedentary job involving extensive use of desktop computers.