The Division of Gastroenterology and Hepatology at the University of Virginia’s (UVA) School of Medicine is currently seeking applicants for a Clinical Research Coordinator (CRC), Licensed or Non-Licensed, to join a dynamic and growing team of clinical research professionals. This position is open to applicants who meet the requirements of Clinical Research Coordinator 1 or 2. The applicant should ideally have some Clinical Research experience and past patient facing clinical activity.

The CRC will work closely with world-renowned Principal Investigators, physicians, research staff, study subjects, and departmental staff during the performance of clinical trials. The Clinical Research Coordinator will perform the responsibilities outlined below and other duties may be assigned.

The incumbent is responsible for maintaining quality management of the trial portfolio and there is often close collaboration with other CRCs on the Research Team.

The Division of Gastroenterology and Hepatology continues to be a leader in national and international pivotal clinical research and our CRCs play a critical role in the success of the Research Program. The CRC will have the opportunity to work on clinical trials that include innovative and cutting-edge therapy of a variety of liver disorders including non-alcoholic fatty liver disease (NASH), autoimmune liver diseases such as Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis, Alcoholic Hepatitis and Wilson Disease. The successful candidate will join a team CRCs actively conducting Clinical Research and a Research Unit Supervisor who oversees operation of the Unit.

Responsibilities:

• Become familiar with study start-up processes and requirements for: non-disclosure agreements, data use and material transfer agreements, clinical trial agreements, development of clinical trial budgets.
• Manage study recruitment and enrollment efforts including screen and identify eligible patients, obtain and document informed consent and enrollment.
• Manage ongoing study conduct activities such as: schedule and coordinate study visits, maintain concomitant medication records, track and report adverse events, organize subject study payments.
• Collect and enter study data in a timely fashion, maintain corresponding documentation.
• Collect, process, store, and ship study specimens as needed.
• Assist in preparation, maintenance, or creation of study documents such as: study visit schedules, study drug diaries, monitoring or training logs, equipment records or study communications.
• Prepare and submit all regulatory documentation to the IRB such as: personnel changes, annual protocol continuations, protocol modifications, adverse event reports, unanticipated events.
• Document and report protocol deviations.
• Reconcile study billing, identify charges covered by the study, versus charges to be billed to the subject/third party payor.
• Confirm Sponsor is invoiced for study activity.
• Notify PI and/or supervisor of any potential issues with the study or subject status.
• Communicate effectively with study Sponsor(s.)
• Proficient user of the various electronic platforms utilized in clinical research such as: IRB Pro, Protocol Builder, CRConnect, OnCore, e-regulatory platforms and Epic.
• Demonstrate a continuously increasing level of clinical research knowledge gained through active participation in training and mentorship opportunities as well as self-guided learning.
• 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. Background in compliance preferred.

Clinical Research Coordinator 1, Licensed
Education: Bachelor's Degree Required or equivalent combination of experience, education, and/or certifications. Nursing Diploma may substitute for Degree for Licensed Registered Nurse.
Experience: None.
Licensure: Licensed to Practice in Clinical Profession such as (but not limited to): Registered Nurse, Athletic Training, Pharmacology, Medical Technology, Physical Therapy or Registered Respiratory Therapy.

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 2, Licensed
Education: Bachelor's Degree Required or equivalent combination of experience, education, and/or certifications. Nursing Diploma may substitute for Degree for Licensed Registered Nurse.
Experience: At least one year of clinical research experience.
Licensure: Licensed to Practice in Clinical Profession such as (but not limited to): Registered Nurse, Athletic Training, Pharmacology, Medical Technology, Physical Therapy or Registered Respiratory Therapy.

Preferred qualifications:

• One year of clinical trials experience.
• Experience in a healthcare setting.
• Previous experience with EPIC EMR, UVA Research platforms, Phlebotomy skills, and experience in a clinical environment.
• Working knowledge of clinical research, Electronic Data Capture systems and/or clinical skills and medical terminology.

This is a full-time, benefited position. For more information on the benefits at UVA, visit www.hr.virginia.edu/benefits. This position is a restricted position and is dependent upon project need, availability of funding and performance. This position is located in Charlottesville, VA. The University will perform background checks on all new hires prior to employment. A completed pre-employment health and drug screening are required for this position.

To Apply:

Please visit UVA job board at https://uva.wd1.myworkdayjobs.com/UVAJobs and search for “ R0048125. ” Internal applicants must apply through your Workday Home page, search “Find Jobs,” and search for “R0048125.”

Complete an application online with the following documents:

• CV

• Cover letter

Upload all materials into the resume submission field, multiple documents can be submitted into this one field. Alternatively, merge all documents into one PDF for submission. Applications that do not contain all required documents will not receive full consideration.

References will be completed via UVA’s standardized process Skill Survey. A total of five references will be requested via SkillSurvey during the final phase of the interview process.

For questions about the application process, please contact Jessica Russo, Recruiting Specialist, at sxv9zv@virginia.edu.

For more information about UVA and the Charlottesville community please see http://www.virginia.edu/life/charlottesville and https://embarkcva.com/.

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, i ncluding 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.