- Work closely with Principal Investigators and other study team members on all clinical research projects assigned.
- 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. Demonstrate a working knowledge of the regulatory framework for FDA and non-FDA regulated studies.
- Manage study recruitment and enrollment efforts including: screen and identify eligible patients, obtain and document informed consent and enrollment.
- 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.
- CV or Resume
- Cover letter
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Clinical Research Coordinator 1-3, Non-Licensed - Charlottesville, United States - University of Virginia
Description
The UVA Center for Psychiatric Clinical Research seeks a non-licensed Clinical Research Coordinator (varying levels) This role requires some previous experience in clinical research.
The CRC will be able to manage the basic elements of clinical trial conduct and demonstrate a solid understanding of clinical research compliance.
The CRC will be involved in most aspects of clinical research conduct and will continue to benefit from the opportunity to engage in additional on-the-job training and mentorship opportunities to continue to advance on the clinical research career path.
The CRC works under the moderate supervision of a Principal Investigator and/or an experienced CRC and will manage a reasonable portfolio of clinical trials or research projects as assigned by a supervisor.
Duties Include:
MINIMUM REQUIREMENTS
Applicants will be considered for the following levels and position types:
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. The job does occasionally require traveling some distance to attend meetings, and programs.
This is a restricted position and is dependent upon project need, availability of funding and performance. For more information on the benefits at UVA, visit
This position will remain open until filled. The University will perform background checks on all new hires prior to employment. A completed pre-employment health screen is required for this position prior to employment.
TO APPLY
Please apply through Careers at UVA, and search for R Internal applicants must apply through their UVA Workday profile by searching 'Find Jobs'.
Complete an application online with the following documents:
References will be completed via UVA's standardized process Skill Survey during the final phase of the interview process. For questions about the application process, please contact Jeremy Brofft, Senior Recruiting Specialist at
For more information about UVA and the Charlottesville community please see and
The University of Virginia, including 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.
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.
