Clinical Research Coordinator 3 or 4, Joint Emerging Diseases Initiative, UVA
Job ID: R0041098 | Clinical Research | Full Time | Charlottesville, VA
The Division of Infectious Diseases and International Health at the University of Virginia (UVA) School of Medicine seeks candidates for a Clinical Research Coordinator 3 or 4, non-licensed or licensed, to assist with oversight of multiple clinical research projects. A Clinical Research Coordinator 3 or 4 will be expected to plan, organize, lead, and perform comprehensive and advanced-level clinical research duties for multiple and/or complex clinical trials. Our preferred candidate for this position will have the ability to directly impact the overall efficiency, productivity, and success of each clinical trial they coordinate. The CRC in this role will be able to work independently and has the authority to interact with internal or external stakeholders involved in a clinical trial or modify clinical trial workflow or processes within their respective department or division to meet the needs of a given study in collaboration with the manager of the team. As a key member of the research team, you will work closely with the Clinical Research Manager and several physician-investigators on our research trials. This position requires the ability to work rotating weekends and on-call shifts, alternating with others within the department, as needed for study requirements. The successful candidate will be required to manage multiple complex clinical trials simultaneously in accordance with current regulatory requirements and maintain all study documentation in a manner that is "audit ready."

This position works closely with world-renowned principal investigators and other research team members who specialize in the management of pulmonary and infectious diseases. We have a varied research portfolio, including industry-sponsored and NIH-funded studies. CRCs will have the opportunity to work on clinical trials that include new therapies for COVID-19 and sepsis.

For more information on the investigators and areas of investigation, please visit:
https://med.virginia.edu/infectious-diseases/research-programs/clinical-trials-group/
https://www.nbc29.com/2021/06/09/infectious-disease-doctor-awarded-his-work-during-pandemic-uva/
https://wina.com/news/064460-uva-looking-for-covid-positive-adults-in-fluvoxamine-trial/
https://www.nbc29.com/2022/02/15/uva-participating-covid-19-treatment-clinical-trial/
https://www.rappnews.com/news/coronavirus/four-promising-covid-19-therapies-being-tested-at-nearby-uva/article_308e6d5e-521d-11eb-b037-c35307b7145a.html

The successful candidate will be expected to:
  • Screen electronic medical records (EMR) for potential study candidates and track screening efforts.
  • Recruit and obtain informed consent from study participants and maintain telephone and in-person contact.
  • Manage ongoing study conduct activities, such as coordinating study visits, maintaining concomitant medication records, tracking and reporting adverse events, and organizing subject study payments.
  • Work closely with principal investigators (PI) and other study team members on all clinical research projects assigned.
  • Ability to work with minimal supervision.
  • Demonstrate a working knowledge of the regulatory framework for FDA and non-FDA regulated studies.
  • Facilitate and/or complete activities required for study start-up, including contract and budget negotiations, regulatory submissions, and all communications with the study sponsor.
  • Coordinate multiple clinical trials or research projects simultaneously or manage large individual clinical trials that may be multicenter and complex in nature.
  • Manage all aspects of ongoing clinical trial conduct from enrollment to off-study visits, data management, safety reporting, and compliance oversight.
  • Prepare and submit all regulatory documentation to the IRB, such as personnel changes, annual protocol continuations, protocol modifications, adverse event reports, and unanticipated events.
  • Reconcile study billing, identifying charges covered by the study versus charges to be billed to the subject/third-party payor.
  • Orient and/or provide basic training to new study team members.
  • Ensure sponsor is invoiced for study activity and reconcile payments received.
  • Notify PI and/or supervisor of any potential issues with the study or subject status.
  • Communicate effectively with study sponsor(s).
  • Liaise with the other departments within the institution to support clinical research activities.
  • Demonstrate a high level of proficiency with the various electronic platforms utilized in clinical research, such as IRB Pro, Protocol Builder, CRConnect, OnCore, e-regulatory platforms, and Epic.
  • Support investigator-initiated research activity by conducting literature searches, collating research material, and assisting with abstract or manuscript preparation.
  • Demonstrate a continuously increasing level of clinical research knowledge gained through active participation in training and mentorship opportunities, as well as self-guided learning.
  • Process, prepare, and ship study research samples.
  • Ability to work a flexible schedule, when needed, given the nature of the studies open to enrollment.
  • Ability to work on weekends, when needed, given the nature of the studies open to enrollment.
  • Enroll COVID-positive patients in the inpatient or outpatient settings.
  • Ability to draw blood when necessary or become phlebotomy-trained.
  • Support and provide guidance to faculty and trainees with clinical research projects in the department.
  • In addition to the above job responsibilities, other duties may be assigned.

Qualified candidates must have:

Clinical Research Coordinator 3, Non-Licensed
  • Education: Associate's degree required; bachelor's or master's degree preferred. Five or more years of clinical research experience may be considered in lieu of a degree.
  • Experience: Minimum of 3 years of clinical research experience required. Master's degree may substitute for 1 year of clinical research experience.
  • Licensure: Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is preferred at the time of hire and is required within one year.

Clinical Research Coordinator 3, Licensed
  • Education: Associate's degree required; bachelor's or master's degree preferred. Nursing diploma may substitute for associate's degree for Licensed Registered Nurse.
  • Experience: A minimum of 3 years of clinical research experience required. Master's or advanced degree may substitute for 1 year of clinical research experience.
  • Licensure: Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required. Licensed to practice as a Registered Nurse.

Clinical Research Coordinator 4, Non-Licensed
  • Education: Bachelor's degree required; master's or other advanced degree preferred.
  • Experience: At least seven years of clinical research experience demonstrating progressive levels of responsibility and complexity of work. Master's or other advanced degree may substitute for one year of clinical research experience.
  • Licensure: Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is preferred at the time of hire and is required within one year.

Clinical Research Coordinator 4, Licensed
  • Education: Associate's degree required; bachelor's or master's degree preferred. Nursing diploma may substitute for associate's degree for Licensed Registered Nurse.
  • Experience: At least seven years of clinical research experience demonstrating progressive levels of responsibility and complexity of work. Master's or other advanced degree may substitute for one year of clinical research experience.
  • Licensure: Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required. Licensed to practice as a Registered Nurse.

Preferred experience:
  • Experience with Epic EMR and collection and processing of blood draws for research.
  • Experience with OnCore, Advarra, and wcg IRB.
  • Experience managing several open clinical trials at the same time.

Required knowledge, skills, and abilities:
  • Excellent interpersonal and communication skills.
  • Ability to work independently and as part of a team.
  • Ability to prioritize competing tasks and take initiative.
  • Ability to plan and execute tasks and projects while maintaining flexibility and keeping the team abreast of status.
  • Effective use of Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required.
  • Experience with Epic EMR, collection of biomarkers such as blood draws, and experience in a clinical environment.

Physical demands:
This is primarily a sedentary job involving extensive use of desktop computers. The job does occasionally require traveling some distance to attend meetings and programs.

The Clinical Research Coordinator 3 or 4 will report to the Clinical Research Manager of the Joint Emerging Diseases Initiative (JEDI) team. For additional information about the position, please contact Dr. Heather M. Haughey, PhD at HMH8F@hscmail.mcc.virginia.edu

This position is located in Charlottesville, VA. This position is a restricted position and is dependent upon project need, availability of funding, and performance. This is an exempt-level, full-time, benefited position. For more information on the benefits at UVA, visit www.hr.virginia.edu/benefits. The position will remain open until filled. This position will not sponsor applicants for work visas. The anticipated hiring range is commensurate with education and experience.

The University will perform background checks on all new hires prior to employment. A completed pre-employment health screen and drug screening are required for this position prior to employment.

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.

 

 

 


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