Clinical Research Coordinator 1/2/3, Neurosurgery

The Rector & Visitors of the University of Virginia; Charlottesville (VA); On-site; USD 60,000 - 90,000; Full time

Job summary

The Department of Neurosurgery at the University of Virginia School of Medicine invites applications for a Clinical Research Coordinator 2/3, Non-Licensed. The role supports multiple trials, ensures patient safety, and drives data capture and quality under Good Clinical Practices.

Responsibilities include consent, data collection, regulatory submissions, and audit preparation, with on-site work in Charlottesville, VA.

Qualifications

• Bachelor's Degree required or equivalent combination of experience, education and/or certifications.
• Experience in clinical research preferred; familiarity with medical terminology is beneficial.

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.
• Enter data into the Database and submit data within required timeframes.
• Monitor sources for regulatory updates and complete Case Report Forms.
• Facilitate audits of study data.

Skills

Good Clinical Practices

Data entry

Regulatory awareness

Communication

Patient safety

Education

Bachelor's Degree Required

Tools

EDC systems

Job description

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/.

JOB 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.
• 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.

MINIMUM REQUIREMENTS

Clinical Research Coordinator 1, Non-Licensed

• Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications.
• Experience: None. 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. Master's degree may substitute for 1 year of clinical research experience.
• Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is preferred at the time of hire and is required within one year.

PHYSICAL DEMANDS

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

This position is located in Charlottesville, VA. Salary will be commensurate with education and experience. This is a benefited position. Learn more about UVA benefits. This is a restricted position, which is dependent on funding and is contingent upon funding availability.

This position is based in Charlottesville, VA, and must be performed fully on-site.

About UVA and the Community

To learn more about UVA and in the Charlottesville area, visit UVA Life and Embark CVA.

Additional Requirements

Background checks, pre-employment health screenings, and drug screening's will be conducted on all new hires prior to employment.

This position will not consider candidates who require immigration sponsorship now or in the future.

Reference Check Process

Reference checks will be completed by UVA's third-party partner, SkillSurvey, during the final phase of the interview. Five references will be requested, with at least three responses required.

The University of Virginia is an equal opportunity employer. All interested persons are encouraged to apply, including veterans and individuals with disabilities. Learn more about UVA's commitment to non-discrimination and equal opportunity employment.